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