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

Description

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 Start Date

March, 07 2017

Estimated Completion Date

November 2018

Interventions

  • Device: Carboxymethylcellulose (CMC)
  • Device: Placebo
  • Device: CSP01

Study ID

Massachusetts General Hospital -- 2016P001751

Status

Recruiting

Trial ID

NCT03054506

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

53

Sponsor

Massachusetts General Hospital

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

Gender

All

Ages

22 Years to 70 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Abbey Bailey 617-643-5742 abailey0@partners.org

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