Status:
COMPLETED
The Plecanatide Chronic Idiopathic Constipation (CIC) Study
Lead Sponsor:
Bausch Health Americas, Inc.
Collaborating Sponsors:
Parexel
Conditions:
Chronic Idiopathic Constipation
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
This is a Phase IIb/III, randomized, double-blind, placebo-controlled, 12-Week, Repeat, Oral Dose Ranging, study to determine the safety and efficacy of plecanatide in patients with chronic idiopathic...
Eligibility Criteria
Inclusion
- 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
- 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 /has any: diseases or conditions associated with constipation (GI or CNS), structural abnormality of the GI tract or gastric bypass surgery, pelvic floor dysfunction, pseudo-obstruction, active infectious gastritis, diverticulitis, anal fissures or any disease or condition that can affect GI motility or defecation or can be associated with abdominal pain
- Unexplained and clinically significant "alarm symptoms" including lower GI bleeding, iron-deficiency anemia, weight loss or systemic signs of infection or colitis.
- Major surgery within 60 days of screening.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
951 Patients enrolled
Trial Details
Trial ID
NCT01429987
Start Date
October 1 2011
End Date
December 1 2012
Last Update
May 28 2019
Active Locations (121)
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1
Coastal Clinical Research, Inc.
Mobile, Alabama, United States, 36608
2
East Valley Gastroenterology and Hepatology Associates, PC
Chandler, Arizona, United States, 85224
3
Genova Clinical Research
Tucson, Arizona, United States, 85704
4
Desert Sun Clinical Research, LLC
Tucson, Arizona, United States, 85710