ConstipationNCT03054506
The Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation
A study testing CSP01 and Carboxymethylcellulose (CMC) in people with Constipation and Chronic Idiopathic Constipation, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Constipation is a common gastrointestinal motility disorder that is often chronic, negatively affects patients' daily lives. Constipation occurs when bowel movements become difficult or less frequent.This study is being done to study the effectiveness of the hydrogel capsule, CSP01, compared to the active control… Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Constipation, Chronic Idiopathic Constipation, Irritable Bowel Syndrome With Constipation
- What is being tested?
- CSP01 and Carboxymethylcellulose (CMC)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2017to 1 Feb 2019
- 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 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 22-70 years old
- BMI >18.5 and <35 kg/m2
- Rome III criteria for functional constipation or IBS-C
- Continued IBS-C or CIC throughout Run-in period
- Compliant with reporting during Run-in (confirm the presence of constipation during the 7-day Run-in baseline period; patients are required to report an average of <3 continuous spontaneous bowel movements [CSBMs] and ≤6 spontaneous bowel movements [SBMs] per week via the interactive web response system).
- Ability to follow verbal and written instructions
- Ability to record daily bowel habits, including frequency, stool consistency (BSFS), straining (EoPS), completeness of evacuation, and Patient Reported Outcomes (PROs) (abdominal discomfort, severity of constipation, bloating, overall relief)
- Informed consent form signed by the subjects
Who cannot join
- History of loose stools
- History of irritable bowel syndrome with diarrhea (IBS-D) or mixed irritable bowel syndrome (IBS-M)
- Non-compliance with reporting during Run-in
- Patients reporting laxative, enema, and/or suppository usage for >2 days or any usage of a prohibited medication during the Run-in period
- Patients reporting watery stools for any SBM (Type 7 on the Bristol Stool Form Scale [BSFS]) or loose (mushy) stools for >1 SBM (Type 6 on the BSFS) in the absence of laxatives during Run-in
- GI motility obstruction or GI tract structural abnormality
Show all 47Show fewer
- Current use of prescribed or illicit opioids
- History of pelvic floor dysfunction
- Need for manual maneuvers in order to achieve a BM
- History of GI lumen surgery at any time or other GI or abdominal operations within 60 days prior to entry into the study
- History of high-dose stimulative or cathartic laxative abuse as judged by investigator team
- Neurological disorders, metabolic disorders, or other significant disease that would impair their ability to participate in the study
- Cardiovascular disease, diabetes, cancer, Crohn's disease, ulcerative colitis
- BMI of <18.5 or >35 kg/m2
- Pregnancy (or positive serum or urine pregnancy test(s) in females of childbearing potential) or lactation
- Absence of contraception in females of childbearing potential
- History of allergic reaction to carboxymethylcellulose, citric acid, sodium stearyl fumarate, raw cane sugar, gelatin, or titanium dioxide
- Administration of investigational products within 1 month prior to Screening Visit
- Exclusion of colonic inertia with symptoms of < 1 BM per 2 weeks
- Subjects anticipating surgical intervention during the study
- Known history of diabetes (type 1 or 2)
- History of eating disorders including binge eating (except mild binge eater)
- Supine SBP > 160 mm Hg and/or supine DBP > 95 mm Hg (mean of two consecutive readings)
- Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening Visit
- History of swallowing disorders
- Esophageal anatomic abnormalities (e.g., webs, diverticuli, rings)
- History of gastric bypass or any other gastric surgery
- History of small bowel resection (except if related to appendectomy)
- History of gastric or duodenal ulcer
- History of gastroparesis
- History of abdominal radiation treatment
- History of pancreatitis
- History of intestinal stricture (e.g., Crohn's disease)
- History of intestinal obstruction or subjects at high risk of intestinal obstruction including suspected small bowel adhesions
- History of malabsorption
- History of sucrose intolerance
- History of hepatitis B or C
- History of human immunodeficiency virus
- History of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer)
- Any other clinically significant disease interfering with the assessments of Gelesis100, according to the Investigator (e.g., disease requiring corrective treatment, potentially leading to study discontinuation)
- HbA1c > 8.5% (> 69 mmol/mol)
- Positive test for drugs in the urine
- Any relevant biochemical abnormality interfering with the assessments of Gelesis100, according to the Investigator
- Antidiabetic medications within 1 month prior to Screening Visit (except stable dose of metformin, ≤ 1500 mg/day, for at least 1 month in subjects with type 2 diabetes)
- Medications requiring mandatory administration with meal at lunch or dinner
- Anticipated requirement for use of prohibited concomitant medications
- Implanted or externally worn medical device such as, but not limited to, a pacemaker, infusion pump, or insulin pump
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Randomized, Single Center, Double-blind, Parallel-group, Placebo-controlled Study Assessing the Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation
Constipation is a common gastrointestinal motility disorder that is often chronic, negatively affects patients' daily lives. Constipation occurs when bowel movements become difficult or less frequent.This study is being done to study the effectiveness of the hydrogel capsule, CSP01, compared to the active control (carboxymethylcellulose) and placebo (non-medicine sugar pill), to relieve constipation among subjects with chronic idiopathic constipation (CIC) or with irritable bowel syndrome with constipation (IBS-C).
- Being tested
- CSP01, Carboxymethylcellulose (CMC), Placebo
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSP01Device
Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
Carboxymethylcellulose (CMC)Device
Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
PlaceboDevice
Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
| Study group | Role | What they receive |
|---|---|---|
| CSP01 | Experimental | Subjects in the experimental group will receive CSP01, a non-systemic, orally administered hydrogel capsule, twice a day. CSP01 capsules are taken prior to a meal with water, after which the small particles within the capsules hydrate and expand in the stomach and small intestine. By acting as a bulking agent and possibly reducing colonic transit time through increase of colonic water content, CSP01 may contribute to constipation relief. Receives: Device: CSP01 |
| Carboxymethylcellulose (CMC) | Active comparator | Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day. Receives: Device: Carboxymethylcellulose (CMC) |
| Placebo | Placebo comparator | Matching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Colonic Transit Time (CTT)
Colonic Transit Time is the amount of time (in minutes) that the SmartPill capsule spent in the large intestine before expulsion. We measured the difference between CTT pre-treatment and post-treatment and calculated the mean difference for each treatment group. Negative values equal a reduction in CTT.
Measured: Up to 1 week; measured once during the run-in-period and again during third week of the treatment period
Secondary outcomes (11)
Complete Spontaneous Bowel Movement (CSBM) Frequency Rate
Average number of Complete Spontaneous Bowel Movements per day (BMs where participant felt that they emptied their bowels). More CSBMs are interpreted as a better outcome.
Measured: 55 days (baseline, treatment, & follow-up)
Stool Consistency
Stool consistency for each bowel movement based on the Bristol Stool Scale A descriptive numerical scale from 1 to 7 where lower numbers indicate constipation, numbers toward the middle indicate normal stool consistence, and the highest numbers indicate diarrhea. Therefore middle scores mean a better outcome
1= hard lumps 2 = lumpy sausage 3 = cracked sausage 4 = smooth sausage 5 = soft lumps 6 = mushy 7 = watery
Measured: 55 days (baseline, treatment, & follow-up)
Ease of Passage Rating
Patient assessment of the ease with which bowel movements are passed using a descriptive numerical scale where lower numbers indicate difficult passage of stool, numbers toward the middle indicate more normal passage of stool, and numbers on the highest end indicate abnormally urgent passage of stool. Middle scores indicate a better outcome.
- = manual disimpaction needed
- = enema needed
- = straining needed
- = normal
- = urgent without pain
- = urgent with pain
- = incontinent
Measured: 55 days (baseline, treatment, & follow-up)
Patient's Assessment of Abdominal Discomfort
Patient's daily assessment of abdominal discomfort using a numerical rating scale of 0 to 10, where 0 = no discomfort at all and 10 = severe discomfort. Higher scores mean a worse outcome.
Measured: 55 days (baseline, treatment, & follow-up)
Patient Assessment of Bloating Severity
Patient's daily assessment of bloating severity using a numerical rating scale from 0 to 10 where 0 = no bloating at all and 10 = severe bloating. Higher scores mean a worse outcome.
Measured: 55 days (baseline, treatment, & follow-up)
Patient Assessment of Constipation Severity
Patient's daily assessment of constipation severity using a numerical rating scale from 0 to 10 where 0 = no constipation at all and 10 = severe constipation. Higher numbers mean a worse outcome.
Measured: 55 days (baseline, treatment, & follow-up)
Relief Rating
Patient's feeling of overall relief after each bowel movement using a numerical rating scale from 0 to 10 where 0 = no relief and 10 = complete relief. Higher scores mean a better outcome (feeling more relief after a bowel movement).
Measured: 55 days (baseline, treatment, & follow-up)
Patient Assessment of Constipation - Symptoms (PAC-SYM)
Patient assessment of constipation symptom severity questionnaire. A validated 12-question questionnaire.
Numerical scale from 0 to 4 where 0 = absent and 4 = very severe. Possible total score ranges from 0 to 48. Higher total PAC-SYM scores mean a worse outcome.
PAC-SYM was completed at four time-points (Day -14, Day 0, Day 15, \& Day 22). Scores were aggregated based on time period as either pre- (Day -14 \& Day 0) or post- (Day 15 \& Day 22) treatment start. Values reported are averages based on patient total scores from these time points. Data was specifically analyzed based on patient diagnosis in addition to treatment.
Measured: Day -14 to Day 22
Patient Assessment of Constipation - Quality of Life (PAC-QOL)
Patient Assessment of Constipation Quality of Life Questionnaire. A validated questionnaire containing 28 total questions with four sub-sections each broadly ranging from "not at all" to "all of the time" on 0 to 4 scales.
Possible total range is 0 to 112. An overall higher total score on the PAC-QOL means a worse outcome. PAC-QOL was completed at four time-points (Day -14, Day 0, Day 15, \& Day 22). Scores were aggregated based on time period as either pre- (Day -14 \& Day 0) or post- (Day 15 \& Day 22) treatment start. Values reported are averages based on patient total scores from these time points. Data was specifically analyzed based on patient diagnosis in addition to treatment.
Measured: Day -14 to Day 22
Need for Rescue Laxatives
Number of total days that rescue laxatives were used by participants in each treatment group.
(The number of days that rescue laxatives were used by each individual patient was calculated and added to the treatment group total)
Measured: 55 days (baseline, treatment, & follow-up)
Spontaneous Bowel Movement (SBM) Frequency
Average number of Spontaneous Bowel Movements per day. (Spontaneous Bowel Movements include both complete and incomplete bowel movements)
Measured: 55 days (baseline, treatment, & follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start7 Mar 2017
- Primary completion10 May 2018
- Study completion1 Feb 2019
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 ConstipationStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gelesis, Inc.
- Responsible party
- Principal investigator, Kyle Staller, MD, MPH, Massachusetts General Hospital
- Investigators
- Kyle Staller, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054506
- Sponsor's protocol ID
- 2016P001751
- Status last verified
- Jul 2019
- First submitted
- 7 Feb 2017
- Last updated
- 20 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Center, Double-blind, Parallel-group, Placebo-controlled Study Assessing the Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation
- ClinicalTrials.gov ID
- NCT03054506
- Acronym / sponsor ID
- 2016P001751
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Gelesis, Inc.
- Study start
- 7 Mar 2017 (actual)
- Primary completion
- 10 May 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 15 Feb 2017 (actual)
- Results
- Posted 20 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Constipation is a common gastrointestinal motility disorder that is often chronic, negatively affects patients' daily lives. Constipation occurs when bowel movements become difficult or less frequent.This study is being done to study the effectiveness of the hydrogel capsule, CSP01, compared to the active control (carboxymethylcellulose) and placebo (non-medicine sugar pill), to relieve constipation among subjects with chronic idiopathic constipation (CIC) or with irritable bowel syndrome with constipation (IBS-C).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CSP01 | Experimental | Device: CSP01Subjects in the experimental group will receive CSP01, a non-systemic, orally administered hydrogel capsule, twice a day. CSP01 capsules are taken prior to a meal with water, after which the small particles within the capsules hydrate and expand in the stomach and small intestine. By acting as a bulking agent and possibly reducing colonic transit time through increase of colonic water content, CSP01 may contribute to constipation relief. |
| Carboxymethylcellulose (CMC) | Active comparator | Device: Carboxymethylcellulose (CMC)Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day. |
| Placebo | Placebo comparator | Device: PlaceboMatching placebo consists of an inert mixture supplied by Gelesis Inc. in identical-appearing capsules.Subjects in the placebo group will be administered 3 capsules of placebo twice a day. |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 22-70 years old
- BMI >18.5 and <35 kg/m2
- Rome III criteria for functional constipation or IBS-C
- Continued IBS-C or CIC throughout Run-in period
- Compliant with reporting during Run-in (confirm the presence of constipation during the 7-day Run-in baseline period; patients are required to report an average of <3 continuous spontaneous bowel movements [CSBMs] and ≤6 spontaneous bowel movements [SBMs] per week via the interactive web response system).
Key exclusion criteria (47 listed)
- History of loose stools
- History of irritable bowel syndrome with diarrhea (IBS-D) or mixed irritable bowel syndrome (IBS-M)
- Non-compliance with reporting during Run-in
- Patients reporting laxative, enema, and/or suppository usage for >2 days or any usage of a prohibited medication during the Run-in period
- Patients reporting watery stools for any SBM (Type 7 on the Bristol Stool Form Scale [BSFS]) or loose (mushy) stools for >1 SBM (Type 6 on the BSFS) in the absence of laxatives during Run-in
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 |
|---|---|---|
| CSP01Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. | Device | CSP01 |
| Carboxymethylcellulose (CMC)Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. | Device | Carboxymethylcellulose (CMC) |
| PlaceboSubjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks. | Device | Placebo |
Primary outcome
Change From Baseline in Colonic Transit Time (CTT)
Time frame: Up to 1 week; measured once during the run-in-period and again during third week of the treatment period
Colonic Transit Time is the amount of time (in minutes) that the SmartPill capsule spent in the large intestine before expulsion. We measured the difference between CTT pre-treatment and post-treatment and calculated the mean difference for each treatment group. Negative values equal a reduction in CTT.
11 secondary outcomes
Complete Spontaneous Bowel Movement (CSBM) Frequency Rate
Time frame: 55 days (baseline, treatment, & follow-up)
Stool Consistency
Time frame: 55 days (baseline, treatment, & follow-up)
Ease of Passage Rating
Time frame: 55 days (baseline, treatment, & follow-up)
Patient's Assessment of Abdominal Discomfort
Time frame: 55 days (baseline, treatment, & follow-up)
Patient Assessment of Bloating Severity
Time frame: 55 days (baseline, treatment, & follow-up)
Patient Assessment of Constipation Severity
Time frame: 55 days (baseline, treatment, & follow-up)
Relief Rating
Time frame: 55 days (baseline, treatment, & follow-up)
Patient Assessment of Constipation - Symptoms (PAC-SYM)
Time frame: Day -14 to Day 22
Patient Assessment of Constipation - Quality of Life (PAC-QOL)
Time frame: Day -14 to Day 22
Need for Rescue Laxatives
Time frame: 55 days (baseline, treatment, & follow-up)
Spontaneous Bowel Movement (SBM) Frequency
Time frame: 55 days (baseline, treatment, & follow-up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
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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.
Kyle Staller, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSP01 and Carboxymethylcellulose (CMC) in people with Constipation and Chronic Idiopathic Constipation, run by Massachusetts General Hospital 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 8 inclusion and 47 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 20 Aug 2019. 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 20 Aug 2019). 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?
Change From Baseline in Colonic Transit Time (CTT) (time frame: Up to 1 week; measured once during the run-in-period and again during third week of the treatment period). 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 20 Aug 2019.