The Plecanatide Chronic Idiopathic Constipation (CIC) Study (NCT01429987) | Clinical Trial Compass
CompletedPhase 2/3
The Plecanatide Chronic Idiopathic Constipation (CIC) Study
United States951 participantsStarted 2011-10
Plain-language summary
This is a randomized, double-blind, placebo controlled, 12 week repeat oral dose, dose ranging study to determine the efficacy and safety of 3 doses of plecanatide compared to placebo in patients with Chronic Idiopathic Constipation (CIC).
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female aged 18-75, inclusive
* Body Mass Index = 18-35 kg/m2, inclusive
* Meets modified Rome III criteria for functional chronic idiopathic constipation for at least 3 months with symptom onset for at least 6 months. Note: For this trial, patients with manual maneuvers required for \>25% of defecations will not be eligible for participation.
* Less than 3 CSBMs per week at baseline and during pretreatment
* Completed a colonoscopy in accordance with medical guidelines as appropriate, with no clinically significant findings
* Patient is willing to discontinue use of supplemental fiber, laxatives, prescription and nonprescription medications, herbal or dietary supplements intended to treat constipation during the screening, pre-treatment, treatment and 2-week post-treatment periods
* Willing to maintain a stable diet during the study.
* Patients with hemorrhoids and/or diverticulosis (NOT diverticulitis) CAN be entered into the study.
Exclusion Criteria:
* Loose stool (mushy) or watery (Bristol score- 6 or 7) stool in the absence of any laxative or prohibited medicine for \> 25% of BMs during the 3 months prior to screening visit OR during the 14 day treatment period
* Patient meets the Rome III criteria for Irritable Bowel Syndrome (IBS-C)
* Active peptic ulcer disease not adequately treated or not stable
* History of cathartic colon, laxative, enema abuse, or ischemic colitis.
* Fecal impaction within 3 months of screening
* Patient has had /…