At a glance
ClinicalIndex Comparison Record- ✓Age 22 to 70 years
- ✓BMI between 18.5 and 35 kg/m²
- ✓Meets Rome III criteria for functional constipation or IBS-C
- ✓Confirmed constipation during 7-day run-in: <3 continuous spontaneous bowel movements per week AND ≤6 spontaneous bowel movements per week
- ✕History of loose stools, watery stools, or IBS with diarrhea/mixed IBS
- ✕Watery stools (Type 7 Bristol Stool Form Scale) or loose/mushy stools >1 per week during run-in
- ✕Current or recent opioid use (prescription or illicit)
- ✕History of pelvic floor dysfunction or need for manual maneuvers to achieve bowel movement
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating CSP01, Carboxymethylcellulose (CMC), and 1 other intervention for Constipation and 2 related conditions. Completed, enrolled 52 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.