Constipation-predominant Irritable Bowel SyndromeNCT01085643
Effect of Lubiprostone on Small Bowel Contractions in Female Patients With Constipation Irritable Bowel Syndrome (C-IBS)
A study testing Lubiprostone in people with Constipation-predominant Irritable Bowel Syndrome, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
Irritable Bowel Syndrome (IBS) is a common disorder, defined by symptom-based diagnostic criteria. The pathogenesis is multifactorial and gut motor dysfunction is considered to be a contributing factor. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Constipation-predominant Irritable Bowel Syndrome
- What is being tested?
- Lubiprostone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Dec 2010
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Constipation predominant IBS (C-IBS) patients diagnosed on the basis of Rome III criteria
- Females 18 years or older with no operations (except for appendectomy) or medical conditions that can affect small bowel motility
- Ability to comply with the requirements of the entire study
- Patient has given written informed consent to participate and is willing to participate in the entire study
- Patients must not be pregnant or nursing as evidenced by a negative serum pregnancy test taken 7-10 days prior to the manometry. Any female with a positive pregnancy test will be immediately discontinued from the study
Who cannot join
- Evidence of structural abnormality of the gastrointestinal tract or disease/conditions. These conditions include (but are not limited to): current evidence of history of inflammatory bowel disease (Crohn's disease or ulcerative colitis), active diverticulitis, duodenal ulcer, erosive esophagitis, gastric ulcer, gastroparesis, gastrointestinal malignancy, Barrett's esophagus, gastrointestinal obstruction, carcinoid syndrome, pancreatitis, cholelithiasis, amyloidosis, ileus, progressive systemic sclerosis (scleroderma), anorexia nervosa
- Patients with previous gastrointestinal surgery other than appendectomy or cholecystectomy
- Evidence of cathartic colon or a history of laxative use, that in the investigator's opinion is consistent with severe laxative dependence such that the patient is likely to require or use laxatives during the study
- Patients with clinically diagnosed diarrhea defined as 3 stools/day that are loose or watery in nature
- Psychosis, schizophrenia, mania, severe depression or major psychiatric illness needing pharmacological treatment. Well-compensated depression does not exclude a potential patient. Antidepressant medication is allowed if patient has been on a stable dose for at least the past 3 months
- Any evidence or treatment of malignancy (other than localized basal cell, squamous cell skin cancer or in-situ uterine cervix cancer that has been resected) within the previous five years
Show all 14Show fewer
- Clinical evidence (including physical examination, laboratory tests and Electrocardiogram) of non-controlled cardiovascular, respiratory, renal, hepatic, hematologic, neurologic, psychiatric diseases or any disease that may interfere with the study
- Existence of surgical or medical conditions that might interfere with the absorption, distribution, metabolism and excretion of the study drug (i.e., gastrectomy, severe renal insufficiency)
- Symptoms of a significant clinical illness in the preceding two weeks prior to the Screening Visit
- Use of any concurrent prohibited medications e.g., drugs that affect Gastrointestinal (GI) motility including lubiprostone, antibiotics (erythromycin), prokinetics, narcotic analgesics, calcium channel blockers, nitroglycerin, and antispasmodics. Patients must not have taken prohibited medications at least 7 days prior to manometry.
- Planned use of drugs or agents 7 days prior to the Screening Visit that affect gastrointestinal motility and/or perceptions including erythromycin
- Use of an investigational drug or participation in an investigational study, within 30 days of the Screening Visit
- Known hypersensitivity to the drug.
- Based on investigator opinion, evidence of alcohol or drug abuse within the past two years
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: The Effect of Lubiprostone on Patterns of Contractions in the Small Bowel in Female Patients With Constipation Predominant Irritable Bowel Syndrome (C-IBS)
Irritable Bowel Syndrome (IBS) is a common disorder, defined by symptom-based diagnostic criteria. The pathogenesis is multifactorial and gut motor dysfunction is considered to be a contributing factor. Changes in motor patterns in the small bowel in IBS patients are quantitative rather than qualitative with no distinct patterns to distinguish patients from healthy individuals. Changes in motor patterns can affect transit of bowel contents. Indeed, variation in intestinal transit was reported in patients with IBS.
Lubiprostone is a novel agent that is Food and Drug Administration (FDA) approved for the treatment of chronic constipation. More recently 2 randomized double-blind, placebo-controlled trials showed the drug to be effective in relieving symptoms in patients with constipation-predominant Irritable Bowel Syndrome (C-IBS), resulting in approval for female patients with C-IBS at a dose of 8 micrograms twice a day.
Read more
The investigators hypothesize that lubiprostone works not just as a laxative, but by actually altering motility patterns in the small intestine of female patients with C-IBS. These alterations can be measured through High Resolution Manometry (HRM), a new technique that uses catheters with multiple closely spaced sensors and special software that uses color schemes to portray a pressure gradient. This technique allows a detailed assessment of the direction and spread of contractions. The investigators would like to use HRM to see if lubiprostone affects intestinal contractions by giving blinded participants lubiprostone and placebo while they are undergoing High Resolution Manometry and seeing if any changes in contractions occur. Participants will be recruited from investigator's clinic. If interested, potential subjects will be provided with a copy of the consent form for review. Patients will be informed that after they have had an opportunity to review the consent form, they may contact the study team to further discuss the research and address any questions/concerns they have.
Participants will undergo a screening visit and a manometry visit. During the screening visit investigators will determine eligibility, including application of inclusion/exclusion criteria and administration of a pregnancy test. Then during the manometry visit patients will receive two capsules, lubiprostone and placebo, three hours apart during HRM. Patients will receive each capsule only once and will not know which order they're receiving them in.
Read the detailed description
Irritable Bowel Syndrome (IBS) is a common disorder, defined by symptom-based diagnostic criteria. The pathogenesis is multifactorial, and gut motor dysfunction is considered to be a contributing factor. Dysmotility affects both the small bowel and the colon. Changes in motor patterns in the small bowel in IBS are quantitative rather than qualitative, with no distinct patterns to distinguish patients from healthy individuals. Changes in motor patterns can potentially affect transit of bowel contents and contribute to symptoms. Indeed, variation in intestinal transit was reported in patients with IBS. Small bowel transit studies, using scintigraphy, radio-opaque markers and hydrogen breath test, have shown that transit is delayed in constipation-predominant Irritable Bowel Syndrome (C-IBS) and accelerated in diarrhea-predominant Irritable Bowel Syndrome (D-IBS).
Lubiprostone is a novel agent that has been Food and Drug Administration (FDA) approved for the treatment of adult males and females with chronic constipation. More recently, 2 randomized, double-blind, placebo-controlled trials showed the drug to be effective in relieving symptoms in patients with C-IBS, resulting in approval for female patients with C-IBS, at a dose of 8 micrograms twice a day.
The investigators hypothesize that lubiprostone works not just as a laxative, but by actually altering motility patterns in the small intestine of female C-IBS patients. These alterations could be measured through High Resolution Manometry (HRM), a new technique that uses catheters with multiple, closely spaced sensors, and special software that uses color schemes to portray a pressure gradient. This technique allows a detailed assessment of the direction and spread of individual contractions.
The investigators would like to use HRM to see if lubiprostone affects intestinal contractions. The investigators would like to achieve this by administering blinded participants lubiprostone and placebo while they are undergoing HRM and seeing if any changes in contractions occur. Participants will be recruited both from the investigator's own clinic and by word of mouth. Patients of the investigators will be approached by a member of the research team during a regularly scheduled clinic visit. If interested, potential subjects will be provided with a copy of the consent form for review. Patients will be given ample time to review the consent form with friends, family, and/or other physicians. Patients will be informed that after they have had an opportunity to review the consent form, they may contact the study team to schedule an appointment with one of the co-investigators to further discuss the research and address any questions or concerns the patient may have. Once all the potential subject's issues and concerns have been addressed, and the individual would like to enroll in the study, an investigator or co-investigator will obtain informed consent. Referring physicians will be asked to give their patients the contact information for the study team and the recruitment process will proceed as described above.
Participants will undergo two visits: a screening visit and a manometry visit. During the screening visit we will determine eligibility, including application of inclusion/exclusion criteria and administration of a pregnancy test. Then during the manometry visit, patients will receive the two capsules (lubiprostone and placebo), three hours apart during HRM. Patients will receive each capsule only once, but they will not know which order they're receiving them in.
Patients may receive lubiprostone without participating in the research study. As lubiprostone is FDA approved, the indications would be the same, however, patients receiving the drug under standard of care would not be undergoing the HRM or receiving a placebo capsule. Patients also may not be required to undergo a washout from their standard medication before starting on lubiprostone.
- Being tested
- Lubiprostone, Placebo
- Keywords
- IBS, Lubiprostone, Small Bowel, High Resolution Manometry, Delayed Intestinal Transit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LubiprostoneDrug
Also called Amitiza
24mcg PO taken once
PlaceboDrug
24mcg placebo capsule taken once
| Study group | Role | What they receive |
|---|---|---|
| Lubiprostone | Active comparator | Same patients are included in both the Lubiprostone arm and the Placebo arm. The reason why the same patients are assigned to two arms is because an effect comparison is done after taking the placebo and later after taking the lubiprostone. Receives: Drug: Lubiprostone |
| Placebo | Placebo comparator | Same patients are included in both the Lubiprostone arm and the Placebo arm. The reason why the same patients are assigned to two arms is because an effect comparison is done after taking the placebo and later after taking the lubiprostone. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Change in Length of Spread of Antegrade Contractions After Placebo.
Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Placebo)and within the following 3 hours.
Measured: baseline and within the following 3 hours
A Change in Length of Spread of Antegrade Contractions After Lubiprostone
Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Placebo)and within the following 3 hours.
Measured: baseline and within the following 3 hours
Secondary outcomes (4)
A Change in Length of Spread of Long Distance Propagating Contractions After Placebo.
Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Placebo)and within the following 3 hours.
Measured: baseline and within the following 3 hours
A Change in Length of Spread of Retrograde Contractions After Placebo
Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Placebo)and within the following 3 hours.
Measured: baseline and within the following 3 hours
A Change in Length of Spread of Long Distance Propagating Contractions After Lubiprostone
Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Lubiprostone)and within the following 3 hours.
Measured: baseline and within the following 3 hours
A Change in Length of Spread of Retrograde Contractions After Lubiprostone
Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Lubiprostone)and within the following 3 hours.
Measured: baseline and within the following 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2010
- Study completionDec 2010
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.
- Other trials for Constipation-predominant Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Responsible party
- Principal investigator, Edy E Soffer, Cedars-Sinai Medical Center
- Investigators
- Edy E Soffer, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085643
- Sponsor's protocol ID
- 17482
- Status last verified
- Nov 2011
- First submitted
- 11 Mar 2010
- Last updated
- 12 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lubiprostone on Patterns of Contractions in the Small Bowel in Female Patients With Constipation Predominant Irritable Bowel Syndrome (C-IBS)
- ClinicalTrials.gov ID
- NCT01085643
- Acronym / sponsor ID
- 17482
- Keywords
- IBS, Lubiprostone, Small Bowel, High Resolution Manometry, Delayed Intestinal Transit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Study start
- Mar 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 12 Mar 2010 (estimated)
- Results
- Posted 12 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Irritable Bowel Syndrome (IBS) is a common disorder, defined by symptom-based diagnostic criteria. The pathogenesis is multifactorial and gut motor dysfunction is considered to be a contributing factor. Changes in motor patterns in the small bowel in IBS patients are quantitative rather than qualitative with no distinct patterns to distinguish patients from healthy individuals. Changes in motor patterns can affect transit of bowel contents. Indeed, variation in intestinal transit was reported in patients with IBS.
Lubiprostone is a novel agent that is Food and Drug Administration (FDA) approved for the treatment of chronic constipation. More recently 2 randomized double-blind, placebo-controlled trials showed the drug to be effective in relieving symptoms in patients with constipation-predominant Irritable Bowel Syndrome (C-IBS), resulting in approval for female patients with C-IBS at a dose of 8 micrograms twice a day.
The investigators hypothesize that lubiprostone works not just as a laxative, but by actually altering motility patterns in the small intestine of female patients with C-IBS. These alterations can be measured through High Resolution Manometry (HRM), a new technique that uses catheters with multiple closely spaced sensors and special software that uses color schemes to portray a pressure gradient. This technique allows a detailed assessment of the direction and spread of contractions. The investigators would like to use HRM to see if lubiprostone affects intestinal contractions by giving blinded participants lubiprostone and placebo while they are undergoing High Resolution Manometry and seeing if any changes in contractions occur. Participants will be recruited from investigator's clinic. If interested, potential subjects will be provided with a copy of the consent form for review. Patients will be informed that after they have had an opportunity to review the consent form, they may contact the study team to further discuss the research and address any questions/concerns they have.
Participants will undergo a screening visit and a manometry visit. During the screening visit investigators will determine eligibility, including application of inclusion/exclusion criteria and administration of a pregnancy test. Then during the manometry visit patients will receive two capsules, lubiprostone and placebo, three hours apart during HRM. Patients will receive each capsule only once and will not know which order they're receiving them in.
Detailed description
Irritable Bowel Syndrome (IBS) is a common disorder, defined by symptom-based diagnostic criteria. The pathogenesis is multifactorial, and gut motor dysfunction is considered to be a contributing factor. Dysmotility affects both the small bowel and the colon. Changes in motor patterns in the small bowel in IBS are quantitative rather than qualitative, with no distinct patterns to distinguish patients from healthy individuals. Changes in motor patterns can potentially affect transit of bowel contents and contribute to symptoms. Indeed, variation in intestinal transit was reported in patients with IBS. Small bowel transit studies, using scintigraphy, radio-opaque markers and hydrogen breath test, have shown that transit is delayed in constipation-predominant Irritable Bowel Syndrome (C-IBS) and accelerated in diarrhea-predominant Irritable Bowel Syndrome (D-IBS).
Lubiprostone is a novel agent that has been Food and Drug Administration (FDA) approved for the treatment of adult males and females with chronic constipation. More recently, 2 randomized, double-blind, placebo-controlled trials showed the drug to be effective in relieving symptoms in patients with C-IBS, resulting in approval for female patients with C-IBS, at a dose of 8 micrograms twice a day.
The investigators hypothesize that lubiprostone works not just as a laxative, but by actually altering motility patterns in the small intestine of female C-IBS patients. These alterations could be measured through High Resolution Manometry (HRM), a new technique that uses catheters with multiple, closely spaced sensors, and special software that uses color schemes to portray a pressure gradient. This technique allows a detailed assessment of the direction and spread of individual contractions.
The investigators would like to use HRM to see if lubiprostone affects intestinal contractions. The investigators would like to achieve this by administering blinded participants lubiprostone and placebo while they are undergoing HRM and seeing if any changes in contractions occur. Participants will be recruited both from the investigator's own clinic and by word of mouth. Patients of the investigators will be approached by a member of the research team during a regularly scheduled clinic visit. If interested, potential subjects will be provided with a copy of the consent form for review. Patients will be given ample time to review the consent form with friends, family, and/or other physicians. Patients will be informed that after they have had an opportunity to review the consent form, they may contact the study team to schedule an appointment with one of the co-investigators to further discuss the research and address any questions or concerns the patient may have. Once all the potential subject's issues and concerns have been addressed, and the individual would like to enroll in the study, an investigator or co-investigator will obtain informed consent. Referring physicians will be asked to give their patients the contact information for the study team and the recruitment process will proceed as described above.
Participants will undergo two visits: a screening visit and a manometry visit. During the screening visit we will determine eligibility, including application of inclusion/exclusion criteria and administration of a pregnancy test. Then during the manometry visit, patients will receive the two capsules (lubiprostone and placebo), three hours apart during HRM. Patients will receive each capsule only once, but they will not know which order they're receiving them in.
Patients may receive lubiprostone without participating in the research study. As lubiprostone is FDA approved, the indications would be the same, however, patients receiving the drug under standard of care would not be undergoing the HRM or receiving a placebo capsule. Patients also may not be required to undergo a washout from their standard medication before starting on lubiprostone.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lubiprostone | Active comparator | Drug: LubiprostoneSame patients are included in both the Lubiprostone arm and the Placebo arm. The reason why the same patients are assigned to two arms is because an effect comparison is done after taking the placebo and later after taking the lubiprostone. |
| Placebo | Placebo comparator | Drug: PlaceboSame patients are included in both the Lubiprostone arm and the Placebo arm. The reason why the same patients are assigned to two arms is because an effect comparison is done after taking the placebo and later after taking the lubiprostone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Constipation predominant IBS (C-IBS) patients diagnosed on the basis of Rome III criteria
- Females 18 years or older with no operations (except for appendectomy) or medical conditions that can affect small bowel motility
- Ability to comply with the requirements of the entire study
- Patient has given written informed consent to participate and is willing to participate in the entire study
- Patients must not be pregnant or nursing as evidenced by a negative serum pregnancy test taken 7-10 days prior to the manometry. Any female with a positive pregnancy test will be immediately discontinued from the study
Key exclusion criteria (14 listed)
- Evidence of structural abnormality of the gastrointestinal tract or disease/conditions. These conditions include (but are not limited to): current evidence of history of inflammatory bowel disease (Crohn's disease or ulcerative colitis), active diverticulitis, duodenal ulcer, erosive esophagitis, gastric ulcer, gastroparesis, gastrointestinal malignancy, Barrett's esophagus, gastrointestinal obstruction, carcinoid syndrome, pancreatitis, cholelithiasis, amyloidosis, ileus, progressive systemic sclerosis (scleroderma), anorexia nervosa
- Patients with previous gastrointestinal surgery other than appendectomy or cholecystectomy
- Evidence of cathartic colon or a history of laxative use, that in the investigator's opinion is consistent with severe laxative dependence such that the patient is likely to require or use laxatives during the study
- Patients with clinically diagnosed diarrhea defined as 3 stools/day that are loose or watery in nature
- Psychosis, schizophrenia, mania, severe depression or major psychiatric illness needing pharmacological treatment. Well-compensated depression does not exclude a potential patient. Antidepressant medication is allowed if patient has been on a stable dose for at least the past 3 months
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 |
|---|---|---|
| LubiprostoneAlso: Amitiza24mcg PO taken once | Drug | Lubiprostone |
| Placebo24mcg placebo capsule taken once | Drug | Placebo |
Primary outcome
A Change in Length of Spread of Antegrade Contractions After Placebo.
Time frame: baseline and within the following 3 hours
Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Placebo)and within the following 3 hours.
A Change in Length of Spread of Antegrade Contractions After Lubiprostone
Time frame: baseline and within the following 3 hours
Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Placebo)and within the following 3 hours.
4 secondary outcomes
A Change in Length of Spread of Long Distance Propagating Contractions After Placebo.
Time frame: baseline and within the following 3 hours
A Change in Length of Spread of Retrograde Contractions After Placebo
Time frame: baseline and within the following 3 hours
A Change in Length of Spread of Long Distance Propagating Contractions After Lubiprostone
Time frame: baseline and within the following 3 hours
A Change in Length of Spread of Retrograde Contractions After Lubiprostone
Time frame: baseline and within the following 3 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Edy E Soffer, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lubiprostone in people with Constipation-predominant Irritable Bowel Syndrome, run by Cedars-Sinai Medical Center 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 5 inclusion and 14 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 12 Dec 2011. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2011). 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?
A Change in Length of Spread of Antegrade Contractions After Placebo. (time frame: baseline and within the following 3 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2011; AzTrials last refreshed its copy on 8 Nov 2026.