The Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation

NCT ID: NCT03054506

Last Updated: 2019-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-07
• Study Completion Date: 2019-02-01

Brief 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 (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).

Conditions

Constipation; Chronic Idiopathic Constipation; Irritable Bowel Syndrome With Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

CSP01

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.

Group Type: EXPERIMENTAL

CSP01

Intervention Type: DEVICE

Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.

Carboxymethylcellulose (CMC)

Subjects in the active control group will receive orally administered 3 capsules of carboxymethylcellulose (CMC) capsules twice a day.

Group Type: ACTIVE_COMPARATOR

Carboxymethylcellulose (CMC)

Intervention Type: DEVICE

Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DEVICE

Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.

Interventions

CSP01

Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.

Intervention Type: DEVICE

Carboxymethylcellulose (CMC)

Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.

Intervention Type: DEVICE

Placebo

Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age 22-70 years old

2. BMI >18.5 and <35 kg/m2

3. Rome III criteria for functional constipation or IBS-C

4. Continued IBS-C or CIC throughout Run-in period

5. 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).

6. Ability to follow verbal and written instructions

7. 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)

8. Informed consent form signed by the subjects

Exclusion Criteria

1. History of loose stools

2. History of irritable bowel syndrome with diarrhea (IBS-D) or mixed irritable bowel syndrome (IBS-M)

3. Non-compliance with reporting during Run-in

4. Patients reporting laxative, enema, and/or suppository usage for >2 days or any usage of a prohibited medication during the Run-in period

5. 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

6. GI motility obstruction or GI tract structural abnormality

7. Current use of prescribed or illicit opioids

8. History of pelvic floor dysfunction

9. Need for manual maneuvers in order to achieve a BM

10. History of GI lumen surgery at any time or other GI or abdominal operations within 60 days prior to entry into the study

11. History of high-dose stimulative or cathartic laxative abuse as judged by investigator team

12. Neurological disorders, metabolic disorders, or other significant disease that would impair their ability to participate in the study

13. Cardiovascular disease, diabetes, cancer, Crohn's disease, ulcerative colitis

14. BMI of <18.5 or >35 kg/m2

15. Pregnancy (or positive serum or urine pregnancy test(s) in females of childbearing potential) or lactation

16. Absence of contraception in females of childbearing potential

17. History of allergic reaction to carboxymethylcellulose, citric acid, sodium stearyl fumarate, raw cane sugar, gelatin, or titanium dioxide

18. Administration of investigational products within 1 month prior to Screening Visit

19. Exclusion of colonic inertia with symptoms of < 1 BM per 2 weeks

20. Subjects anticipating surgical intervention during the study

21. Known history of diabetes (type 1 or 2)

22. History of eating disorders including binge eating (except mild binge eater)

23. Supine SBP > 160 mm Hg and/or supine DBP > 95 mm Hg (mean of two consecutive readings)

24. Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening Visit

25. History of swallowing disorders

26. Esophageal anatomic abnormalities (e.g., webs, diverticuli, rings)

27. History of gastric bypass or any other gastric surgery

28. History of small bowel resection (except if related to appendectomy)

29. History of gastric or duodenal ulcer

30. History of gastroparesis

31. History of abdominal radiation treatment

32. History of pancreatitis

33. History of intestinal stricture (e.g., Crohn's disease)

34. History of intestinal obstruction or subjects at high risk of intestinal obstruction including suspected small bowel adhesions

35. History of malabsorption

36. History of sucrose intolerance

37. History of hepatitis B or C

38. History of human immunodeficiency virus

39. History of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer)

40. 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)

41. HbA1c > 8.5% (> 69 mmol/mol)

42. Positive test for drugs in the urine

43. Any relevant biochemical abnormality interfering with the assessments of Gelesis100, according to the Investigator

44. 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)

45. Medications requiring mandatory administration with meal at lunch or dinner

46. Anticipated requirement for use of prohibited concomitant medications

47. Implanted or externally worn medical device such as, but not limited to, a pacemaker, infusion pump, or insulin pump

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gelesis, Inc.

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kyle Staller, MD, MPH

Kyle Staller, MD, MPH

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyle Staller, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2016P001751

Identifier Type: -

Identifier Source: org_study_id