Clinical trial NCT03054506: The Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Chronic Idiopathic Constipation
Irritable Bowel Syndrome With Constipation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Gelesis, Inc.
First posted: 2017-02-15
Enrollment: 52
Sex: ALL
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Change From Baseline in Colonic Transit Time (CTT)
timeFrame: Up to 1 week; measured once during the run-in-period and again during third week of the treatment period
Secondary outcomes:
measure: Complete Spontaneous Bowel Movement (CSBM) Frequency Rate
timeFrame: 55 days (baseline, treatment, & follow-up)
measure: Stool Consistency
timeFrame: 55 days (baseline, treatment, & follow-up)
measure: Ease of Passage Rating
timeFrame: 55 days (baseline, treatment, & follow-up)
measure: Patient's Assessment of Abdominal Discomfort
timeFrame: 55 days (baseline, treatment, & follow-up)
measure: Patient Assessment of Bloating Severity
timeFrame: 55 days (baseline, treatment, & follow-up)
measure: Patient Assessment of Constipation Severity
timeFrame: 55 days (baseline, treatment, & follow-up)
measure: Relief Rating
timeFrame: 55 days (baseline, treatment, & follow-up)
measure: Patient Assessment of Constipation - Symptoms (PAC-SYM)
timeFrame: Day -14 to Day 22
measure: Patient Assessment of Constipation - Quality of Life (PAC-QOL)
timeFrame: Day -14 to Day 22
measure: Need for Rescue Laxatives
timeFrame: 55 days (baseline, treatment, & follow-up)
measure: Spontaneous Bowel Movement (SBM) Frequency
timeFrame: 55 days (baseline, treatment, & follow-up)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Kyle Staller, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: