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

Completed · Not applicable · Has a placebo group

Conditions studied: Constipation, Chronic Idiopathic Constipation, Irritable Bowel Syndrome With Constipation

In brief

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).

Key facts

Study ID

NCT03054506

Run by

Massachusetts General Hospital

People needed

52

Starts

2017-03-07

Expected to finish

2019-02-01

Last updated by the study team

2019-08-20

Who can join

Age: 22 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.