Irritable Bowel Syndrome Constipation PredominantPhase 1/2NCT01056107
Effects of ROSE-010 on GI Transit in Constipation Predominant Irritable Bowel Syndrome (C-IBS) Patients
A Phase 1/2 study testing ROSE-010 in people with Irritable Bowel Syndrome Constipation Predominant, run by Mayo Clinic at 1 site in United States.
Trial summary
This trial will study the effects of an investigational (not FDA approved) medication, ROSE-010, on the movement of food through the stomach, small intestine and colon in females with constipation predominant irritable bowel syndrome (C-IBS). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Irritable Bowel Syndrome Constipation Predominant
- What is being tested?
- ROSE-010
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female aged 18-65 years old inclusive.
- A previous diagnosis of IBS according to Rome III criteria to include those patients who have had recurrent abdominal pain or discomfort for the at least the six months prior to diagnosis and currently at least three days per month in the last three months associated with two or more of the following:
- improvement with defecation
- onset associated with a change in the frequency of stool
- onset associated with a change in form (appearance) of stool.
- Constipation predominant type IBS as defined by one or more of the following:
Show all 12Show fewer
- fewer than three spontaneous complete bowel movements per week
- hard or lumpy stools more than 25% of the time
- straining during a bowel movement more than 25% of the time.
- A normal rectal exam result on file within the past two years or performed at screen to exclude the possibility of an evacuation disorder. Examination must exclude findings suggestive of an evacuation disorder such as high sphincter tone at rest, failure of perineal descent by more than one centimeter on straining and last, spasm, tenderness or paradoxical contraction of the puborectalis muscles.
- Females of child bearing potential (those who have not experienced a bilateral tubal ligation, hysterectomy or menopause) must use an acceptable method of contraception during the study. Acceptable methods are surgical sterilization, hormonal methods such as oral contraceptives, Norplant and Depo-Provera, double barrier method such as a condom and spermicide, and an intrauterine device (IUD). Abstinent females may participate if they agree to use the double barrier method should they become sexually active during the study.
- Able to provide written informed consent prior to any study procedures being performed.
Who cannot join
- Female patients who are pregnant or breast-feeding.
- Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders other than C-IBS.
- Unable to withdraw medications 48 hours prior to the study: any medication that alters GI transit including but not limited to laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants and serotonin-norepinephrine reuptake inhibitors (SNRIs); analgesic drugs including opiates, nonsteroidal anti-inflammatory drugs (NSAIDs), and COX 2 inhibitors (Note: Tylenol is permitted), GABAergic agents and benzodiazepines. Note: All other concomitant medications will be reviewed on a case by case basis by the study physicians.
- Clinical evidence (including but not limited to a clinically significant abnormal physical exam, ECG or laboratory result in the past medical record) or current clinically significant abnormal physical exam or laboratory test result that could indicate significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other diseases that interfere with the objectives of the study. If a laboratory test result is abnormal and clinically significant, it may be repeated once at the discretion of the PI. If the laboratory test result remains abnormal and clinically significant, the patient will be referred to a primary care physician for further evaluation.
- Patients who are considered by the Investigator to be alcoholics not in remission or known substance abusers.
- Patients who have participated in another clinical study within the past 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of ROSE-010 on Gastrointestinal Motor Functions in Female Patients With Constipation Predominant Irritable Bowel Syndrome (C-IBS)
This trial will study the effects of an investigational (not FDA approved) medication, ROSE-010, on the movement of food through the stomach, small intestine and colon in females with constipation predominant irritable bowel syndrome (C-IBS).
The study hypothesis is that ROSE-010 will delay gastric emptying of solids and enhances gastric accommodation without retarding colonic transit in female patients with C-IBS.
Read the detailed description
Methodology
Female patients with C-IBS will be screened for eligibility and informed about the study at the initial screening visit Visit 1. Within two weeks of Visit 1, eligible patients will be randomized to study medication, either 30 mcg, 100 mcg or 300 mcg ROSE-010 or placebo administered via abdominal subcutaneous (s.c.) injection for a total of four days, three consecutive days during transit scintigraphy and once prior to SPECT imaging. The allocation to treatment group will be concealed.
Study medication will be administered at Visits 2, 3, and 4, the days of scintigraphic assessment of gastric, small bowel and colonic transit of solids performed over a 48 hour period.
Within two to seven days of Visit 4, patients will be instructed to return for administration of a final injection of study medication followed by SPECT gastric accommodation measurements (Visit 5). Within seven to ten days of Visit 5, patients will return for Visit 6, final safety monitoring and an exit interview with study staff.
Investigational product, dosage and mode of administration
Patients will receive placebo or 30 mcg, 100 mcg or 300 mcg ROSE-010 administered s.c. in the abdomen once on Visit 2, immediately before the standardized breakfast meal, fifteen minutes before the first camera image is obtained. Study medication will be administered fifteen minutes before camera images obtained on Visits 3 and 4. Study medication will be administered immediately after the first fasting scan is obtained and before the second fasting scan during SPECT at Visit 5.
Duration of treatment
ROSE-010 or matching placebo will be administered via abdominal s.c injection once daily for three consecutive days and one final day two to seven days later, over a ten-day interval.
Duration of patients involvement in the study
Each patient will attend six visits at the clinic during a period of two to four weeks.
Efficacy assessments
- Scintigraphic gastrointestinal and colonic transit
- Technetium-99m (99mTc) SPECT measurement of gastric volumes
- Assessment of stool frequency and consistency made by the patient using the Bowel Pattern Diary
Safety assessments
The following safety assessments will be performed:
- Laboratory safety tests, including a complete blood count (CBC), a comprehensive metabolic panel (CMP), and urinalysis (UA) at Visit 1 (study entry) and Visit 6 (study exit)
- A physical examination by a study physician at Visit 1
- Weight and vital signs (including temperature, pulse, blood pressure and respiration rate) at every visit
- Urine pregnancy tests performed at Visit 1 and within 48 hours prior to receipt of radiation at Visit 2 transit test and Visit 5 SPECT test
- Interview for concomitant medications and adverse events at every visit
Statistical methods
An analysis of covariance (ANCOVA) will be used to compare transit parameters and gastric volumes among the treatment groups. If necessary a suitable transformation for potential skewness in the distributions of measured volumes may be used (e.g., ANCOVA on ranks or log volumes). If ANCOVA shows a p value less than or equal to 0.10, then both the 100 mcg and 300 mcg doses will be compared to placebo (p value less than or equal to 0.25). Dunnett's Test will be used to compare each dose group with placebo. Since each of the primary endpoints assesses a separate hypothesis regarding the effects of ROSE-010, no adjustment in the alpha level for testing multiple types of endpoints is anticipated, and a two-sided significance level of 0.05 will be used in each ANCOVA model.
Analysis data sets
The primary analyses will follow the intent to treat (ITT) paradigm with all patients randomized included in the analyses. Those patients with missing response values will have their missing values imputed via the overall (patients with non-missing data) mean and a corresponding adjustment in the ANCOVA residual error variance degrees of freedom (subtracting one for each missing value imputed). Safety data will be presented for all patients receiving investigational product.
- Being tested
- ROSE-010, Placebo
- Keywords
- Constipation, Irritable Bowel Syndrome (IBS), Glucagon Like Peptide analogue
- Medical subject headings
- Constipation, Irritable Bowel Syndrome, Ichthyosis Bullosa of Siemens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROSE-010Drug
Also called Glucagon-like peptide-1 (GLP-1) analogue
The study medication was used in 30 mcg, 100 mcg, and 300 mcg subcutaneous injections daily, depending upon study arm.
PlaceboDrug
Also called Glucagon-like peptide-1 (GLP-1) analogue
Placebo subcutaneous injection daily
| Study group | Role | What they receive |
|---|---|---|
| ROSE-010 30 mcg | Experimental | A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later. Receives: Drug: ROSE-010 |
| ROSE-010 100 mcg | Experimental | A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later. Receives: Drug: ROSE-010 |
| ROSE-010 300 mcg | Experimental | A glucagon-like peptide-1 (GLP-1) analogue. A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later. Receives: Drug: ROSE-010 |
| Placebo | Placebo comparator | Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonic Transit, Colonic Geometric Center at 24 Hours
The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.
Measured: 24 hours (Visit 3 = Day 1)
Change Between Postprandial and Fasting Whole Gastric Volume by Technetium-99m (99mTc)-SPECT Imaging (Gastric Accommodation)
A noninvasive SPECT method was used to measure gastric volume during fasting and 32 min after a liquid nutritional supplement meal. Subjects reported to the clinic after an overnight fast. 99mTC was giving by an intravenous injection in the forearm. The first fasting scan was obtained, and the study medication was given s.c. After 10 min, a 2nd fasting post medication scan was obtained, and the meal consumed; then two serial postprandial scans were obtained. Each scan required 9-12 min. Tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content. For this outcome measure, the scans for the "fasting volume" and 2 "postprandial volumes" were used. The 2 postprandial (PP) volumes were averaged. Change was calculated as (PP - Fasting = gastric accommodation).
Measured: approximately 1 hour after 99mTC injection, approximately 30 min after liquid meal (Visit 5 = approximately 2-10 days after Visit 4)
Half Time (t1/2) of Gastric Emptying of Solids Measured by Scintigraphy (Gastric Transit)
Half time (t1/2) of gastric emptying (GE) of solids is the time for half of the ingested solids or liquids to leave the stomach. The scintigraphy for GE t1/2 was done on Visit 2 (Day 0 of the study), the first day of scintigraphy.
Measured: approximately 2 hours after radiolabeled meal is ingested (Visit 2 = Day 0)
Secondary outcomes (7)
Gastric Residual at 2 and 4 Hours Measured by Scintigraphy
The gastric residual will be calculated as the proportion of isotope remaining in the stomach (at 2 and 4 hours).
Measured: 2 hours, 4 hours (Visit 2 = Day 0)
Colonic Geometric Center at 4 h Measured by Scintigraphy
The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. (Note: when there is no radio isotope in the colon (e.g., at 4 hours) the geometric center values are recorded as "zero," thus the mean values can be less than one.)
Measured: 4 hours (Visit 2 = Day 0)
Colonic Filling at 6 h Measured by Scintigraphy
Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.
Measured: 6 hours (Visit 2 = Day 0)
Ascending Colon Emptying Half-time (AC t1/2) Measured by Scintigraphy
Ascending colon emptying half-time will be estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. The primary data for this analysis will be the proportion of decay and depth-corrected counts in the ascending colon on the hourly scans on the first day of transit measurement and the 48 hour data.
Measured: 48 hours (Visit 4 = Day 2)
Colonic Transit, Colonic Geometric Center at 48 h Measured by Scintigraphy, as Compared to Placebo.
The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.
Measured: 48 hours (Visit 4 = Day 2)
Stool Frequency
Stool frequency was self reported in a Bowel Pattern Diary. The bowel pattern diary was dispensed at the screening visit, and the completed bowel pattern diary was collected at the completion of the study.
Measured: screening visit (Visit 1), 34 days (Visit 6)
Stool Consistency Post Treatment
The subjects rated their stool consistency using the 7-point Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the "ideal stools" especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea. The Bristol stool form was part of the bowel pattern diary, which was dispensed at the screening visit, and the completed bowel pattern diary was collected at the completion of the study.
Measured: 34 days (Visit 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel Syndrome Constipation PredominantStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Rose Pharma A/S, National Center for Research Resources (NCRR)
- Responsible party
- Principal investigator, Michael Camilleri, Mayo Clinic
- Investigators
- Michael Camilleri, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056107
- Sponsor's protocol ID
- 09-005871
- Other IDs
- UL1RR024150
- Status last verified
- Apr 2013
- First submitted
- 22 Jan 2010
- Last updated
- 31 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Camilleri M, Vazquez-Roque M, Iturrino J, Boldingh A, Burton D, McKinzie S, Wong BS, Rao AS, Kenny E, Mansson M, Zinsmeister AR. Effect of a glucagon-like peptide 1 analog, ROSE-010, on GI motor functions in female patients with constipation-predominant irritable bowel syndrome. Am J Physiol Gastrointest Liver Physiol. 2012 Jul;303(1):G120-8. doi: 10.1152/ajpgi.00076.2012. Epub 2012 Apr 19.
PubMed 22517769
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of ROSE-010 on Gastrointestinal Motor Functions in Female Patients With Constipation Predominant Irritable Bowel Syndrome (C-IBS)
- ClinicalTrials.gov ID
- NCT01056107
- Acronym / sponsor ID
- 09-005871
- Keywords
- Constipation, Irritable Bowel Syndrome (IBS), Glucagon Like Peptide analogue
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Rose Pharma A/S, National Center for Research Resources (NCRR)
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 26 Jan 2010 (estimated)
- Results
- Posted 31 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will study the effects of an investigational (not FDA approved) medication, ROSE-010, on the movement of food through the stomach, small intestine and colon in females with constipation predominant irritable bowel syndrome (C-IBS).
The study hypothesis is that ROSE-010 will delay gastric emptying of solids and enhances gastric accommodation without retarding colonic transit in female patients with C-IBS.
Detailed description
Methodology
Female patients with C-IBS will be screened for eligibility and informed about the study at the initial screening visit Visit 1. Within two weeks of Visit 1, eligible patients will be randomized to study medication, either 30 mcg, 100 mcg or 300 mcg ROSE-010 or placebo administered via abdominal subcutaneous (s.c.) injection for a total of four days, three consecutive days during transit scintigraphy and once prior to SPECT imaging. The allocation to treatment group will be concealed.
Study medication will be administered at Visits 2, 3, and 4, the days of scintigraphic assessment of gastric, small bowel and colonic transit of solids performed over a 48 hour period.
Within two to seven days of Visit 4, patients will be instructed to return for administration of a final injection of study medication followed by SPECT gastric accommodation measurements (Visit 5). Within seven to ten days of Visit 5, patients will return for Visit 6, final safety monitoring and an exit interview with study staff.
Investigational product, dosage and mode of administration
Patients will receive placebo or 30 mcg, 100 mcg or 300 mcg ROSE-010 administered s.c. in the abdomen once on Visit 2, immediately before the standardized breakfast meal, fifteen minutes before the first camera image is obtained. Study medication will be administered fifteen minutes before camera images obtained on Visits 3 and 4. Study medication will be administered immediately after the first fasting scan is obtained and before the second fasting scan during SPECT at Visit 5.
Duration of treatment
ROSE-010 or matching placebo will be administered via abdominal s.c injection once daily for three consecutive days and one final day two to seven days later, over a ten-day interval.
Duration of patients involvement in the study
Each patient will attend six visits at the clinic during a period of two to four weeks.
Efficacy assessments
- Scintigraphic gastrointestinal and colonic transit
- Technetium-99m (99mTc) SPECT measurement of gastric volumes
- Assessment of stool frequency and consistency made by the patient using the Bowel Pattern Diary
Safety assessments
The following safety assessments will be performed:
- Laboratory safety tests, including a complete blood count (CBC), a comprehensive metabolic panel (CMP), and urinalysis (UA) at Visit 1 (study entry) and Visit 6 (study exit)
- A physical examination by a study physician at Visit 1
- Weight and vital signs (including temperature, pulse, blood pressure and respiration rate) at every visit
- Urine pregnancy tests performed at Visit 1 and within 48 hours prior to receipt of radiation at Visit 2 transit test and Visit 5 SPECT test
- Interview for concomitant medications and adverse events at every visit
Statistical methods
An analysis of covariance (ANCOVA) will be used to compare transit parameters and gastric volumes among the treatment groups. If necessary a suitable transformation for potential skewness in the distributions of measured volumes may be used (e.g., ANCOVA on ranks or log volumes). If ANCOVA shows a p value less than or equal to 0.10, then both the 100 mcg and 300 mcg doses will be compared to placebo (p value less than or equal to 0.25). Dunnett's Test will be used to compare each dose group with placebo. Since each of the primary endpoints assesses a separate hypothesis regarding the effects of ROSE-010, no adjustment in the alpha level for testing multiple types of endpoints is anticipated, and a two-sided significance level of 0.05 will be used in each ANCOVA model.
Analysis data sets
The primary analyses will follow the intent to treat (ITT) paradigm with all patients randomized included in the analyses. Those patients with missing response values will have their missing values imputed via the overall (patients with non-missing data) mean and a corresponding adjustment in the ANCOVA residual error variance degrees of freedom (subtracting one for each missing value imputed). Safety data will be presented for all patients receiving investigational product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ROSE-010 30 mcg | Experimental | Drug: ROSE-010A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later. |
| ROSE-010 100 mcg | Experimental | Drug: ROSE-010A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later. |
| ROSE-010 300 mcg | Experimental | Drug: ROSE-010A glucagon-like peptide-1 (GLP-1) analogue. A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Female aged 18-65 years old inclusive.
- A previous diagnosis of IBS according to Rome III criteria to include those patients who have had recurrent abdominal pain or discomfort for the at least the six months prior to diagnosis and currently at least three days per month in the last three months associated with two or more of the following:
- Constipation predominant type IBS as defined by one or more of the following:
- A normal rectal exam result on file within the past two years or performed at screen to exclude the possibility of an evacuation disorder. Examination must exclude findings suggestive of an evacuation disorder such as high sphincter tone at rest, failure of perineal descent by more than one centimeter on straining and last, spasm, tenderness or paradoxical contraction of the puborectalis muscles.
- Females of child bearing potential (those who have not experienced a bilateral tubal ligation, hysterectomy or menopause) must use an acceptable method of contraception during the study. Acceptable methods are surgical sterilization, hormonal methods such as oral contraceptives, Norplant and Depo-Provera, double barrier method such as a condom and spermicide, and an intrauterine device (IUD). Abstinent females may participate if they agree to use the double barrier method should they become sexually active during the study.
Key exclusion criteria (6 listed)
- Female patients who are pregnant or breast-feeding.
- Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders other than C-IBS.
- Unable to withdraw medications 48 hours prior to the study: any medication that alters GI transit including but not limited to laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants and serotonin-norepinephrine reuptake inhibitors (SNRIs); analgesic drugs including opiates, nonsteroidal anti-inflammatory drugs (NSAIDs), and COX 2 inhibitors (Note: Tylenol is permitted), GABAergic agents and benzodiazepines. Note: All other concomitant medications will be reviewed on a case by case basis by the study physicians.
- Clinical evidence (including but not limited to a clinically significant abnormal physical exam, ECG or laboratory result in the past medical record) or current clinically significant abnormal physical exam or laboratory test result that could indicate significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other diseases that interfere with the objectives of the study. If a laboratory test result is abnormal and clinically significant, it may be repeated once at the discretion of the PI. If the laboratory test result remains abnormal and clinically significant, the patient will be referred to a primary care physician for further evaluation.
- Patients who are considered by the Investigator to be alcoholics not in remission or known substance abusers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROSE-010Also: Glucagon-like peptide-1 (GLP-1) analogueThe study medication was used in 30 mcg, 100 mcg, and 300 mcg subcutaneous injections daily, depending upon study arm. | Drug | ROSE-010 100 mcg, ROSE-010 30 mcg, ROSE-010 300 mcg |
| PlaceboAlso: Glucagon-like peptide-1 (GLP-1) analoguePlacebo subcutaneous injection daily | Drug | Placebo |
Primary outcome
Colonic Transit, Colonic Geometric Center at 24 Hours
Time frame: 24 hours (Visit 3 = Day 1)
The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.
Change Between Postprandial and Fasting Whole Gastric Volume by Technetium-99m (99mTc)-SPECT Imaging (Gastric Accommodation)
Time frame: approximately 1 hour after 99mTC injection, approximately 30 min after liquid meal (Visit 5 = approximately 2-10 days after Visit 4)
A noninvasive SPECT method was used to measure gastric volume during fasting and 32 min after a liquid nutritional supplement meal. Subjects reported to the clinic after an overnight fast. 99mTC was giving by an intravenous injection in the forearm. The first fasting scan was obtained, and the study medication was given s.c. After 10 min, a 2nd fasting post medication scan was obtained, and the meal consumed; then two serial postprandial scans were obtained. Each scan required 9-12 min. Tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content. For this outcome measure, the scans for the "fasting volume" and 2 "postprandial volumes" were used. The 2 postprandial (PP) volumes were averaged. Change was calculated as (PP - Fasting = gastric accommodation).
Half Time (t1/2) of Gastric Emptying of Solids Measured by Scintigraphy (Gastric Transit)
Time frame: approximately 2 hours after radiolabeled meal is ingested (Visit 2 = Day 0)
Half time (t1/2) of gastric emptying (GE) of solids is the time for half of the ingested solids or liquids to leave the stomach. The scintigraphy for GE t1/2 was done on Visit 2 (Day 0 of the study), the first day of scintigraphy.
7 secondary outcomes
Gastric Residual at 2 and 4 Hours Measured by Scintigraphy
Time frame: 2 hours, 4 hours (Visit 2 = Day 0)
Colonic Geometric Center at 4 h Measured by Scintigraphy
Time frame: 4 hours (Visit 2 = Day 0)
Colonic Filling at 6 h Measured by Scintigraphy
Time frame: 6 hours (Visit 2 = Day 0)
Ascending Colon Emptying Half-time (AC t1/2) Measured by Scintigraphy
Time frame: 48 hours (Visit 4 = Day 2)
Colonic Transit, Colonic Geometric Center at 48 h Measured by Scintigraphy, as Compared to Placebo.
Time frame: 48 hours (Visit 4 = Day 2)
Stool Frequency
Time frame: screening visit (Visit 1), 34 days (Visit 6)
Stool Consistency Post Treatment
Time frame: 34 days (Visit 6)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22517769Camilleri M, Vazquez-Roque M, Iturrino J, Boldingh A, Burton D, McKinzie S, Wong BS, Rao AS, Kenny E, Mansson M, Zinsmeister AR. Effect of a glucagon-like peptide 1 analog, ROSE-010, on GI motor functions in female patients with constipation-predominant irritable bowel syndrome. Am J Physiol Gastrointest Liver Physiol. 2012 Jul;303(1):G120-8. doi: 10.1152/ajpgi.00076.2012. Epub 2012 Apr 19.
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Chronic Idiopathic Constipation, Irritable Bowel Syndrome (IBS-C)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Camilleri, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ROSE-010 in people with Irritable Bowel Syndrome Constipation Predominant, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colonic Transit, Colonic Geometric Center at 24 Hours (time frame: 24 hours (Visit 3 = Day 1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01056107, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2013.