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

Inclusion criteria

• 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

Exclusion criteria

• 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
• Esophageal anatomic abnormalities (e.g., webs, diverticuli, rings)
• History of gastric bypass or any other gastric surgery
• History of small bowel resection (except if related to appendectomy)
• History of gastric or duodenal ulcer
• History of gastroparesis
• History of abdominal radiation treatment
• History of pancreatitis
• History of intestinal stricture (e.g., Crohn's disease)
• History of intestinal obstruction or subjects at high risk of intestinal obstruction including suspected small bowel adhesions
• History of malabsorption
• History of sucrose intolerance
• History of hepatitis B or C
• History of human immunodeficiency virus
• History of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer)
• 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)
• HbA1c > 8.5% (> 69 mmol/mol)
• Positive test for drugs in the urine
• Any relevant biochemical abnormality interfering with the assessments of Gelesis100, according to the Investigator
• 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)
• Medications requiring mandatory administration with meal at lunch or dinner
• Anticipated requirement for use of prohibited concomitant medications
• Implanted or externally worn medical device such as, but not limited to, a pacemaker, infusion pump, or insulin pump