Trial record 2 of 5 for:    plecanatide

12-Week Study of Plecanatide for CIC (The CIC3 Study)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Synergy Pharmaceuticals Inc.
Sponsor:
Information provided by (Responsible Party):
Synergy Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01982240
First received: November 5, 2013
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to confirm that the investigational medication, plecanatide, is safe and effective in treating chronic idiopathic constipation.


Condition Intervention Phase
Chronic Idiopathic Constipation
Drug: Plecanatide
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, 12-Week, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Plecanatide (3.0 and 6.0 mg) in Patients With Chronic Idiopathic Constipation (The CIC3 Study)

Resource links provided by NLM:


Further study details as provided by Synergy Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Proportion of patients who are overall responders [ Time Frame: 12-week Treatment Period ] [ Designated as safety issue: No ]

    The study's primary efficacy endpoint is the proportion of patients who are overall responders for the 12-week Treatment Period.

    An overall responder is defined as a weekly responder for at least 9 of the 12 treatment weeks, including at least 3 of the last 4 weeks. A weekly responder is defined as a patient who has ≥ 3 CSBMs per week and an increase from baseline of ≥1 CSBM for that week. A CSBM is a bowel movement that occurs in the absence of laxative use within 24 hours and is associated with the feeling of complete evacuation.



Estimated Enrollment: 1350
Study Start Date: November 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Plecanatide 3.0 mg
Plecanatide tablets 3.0 mg QD for 12 weeks
Drug: Plecanatide
Experimental: Plecanatide 6.0 mg
Plecanatide tablets 6.0 mg QD for 12 weeks
Drug: Plecanatide
Placebo Comparator: Placebo
Matching placebo tablets QD for 12 weeks
Drug: Placebo

Detailed Description:

This is a randomized, 12-week, double-blind, placebo-controlled, study in approximately 1350 adult male and female patients with CIC comparing 2 doses of plecanatide to placebo. The study will be conducted at approximately 180 clinical study sites in the United States (US) and Canada. The primary objective of the study is to evaluate the efficacy and safety of 3.0 and 6.0 mg of plecanatide administered once daily (QD) for 12 weeks in a population of patients with CIC. The study population will include only patients without other causes of constipation or other chronic conditions that could interfere with study assessments. Patients may not take laxatives (with the exception of the study-provided rescue medication, bisacodyl 5mg tablets), or a number of prohibited drugs that are known to cause constipation or diarrhea, during study participation.

There are 6 scheduled study visits, including the screening and follow-up visits. The planned duration of participation in this study will be 112 days and up to 155 days, with washout and all visit windows considered.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female aged 18-80, inclusive
  • Meets modified Rome III criteria for functional chronic idiopathic constipation for at least 3 months with symptom onset for at least 6 months
  • Completed a colonoscopy in accordance with AGA colon cancer screening guidelines (5 years), with no clinically significant findings
  • Willing to maintain a stable diet during 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 pre-treatment assessment
  • Active peptic ulcer disease, diabetes or hypertension 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, stroke or MI within 60 days of screening
  • Participated in a previous plecanatide clinical trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01982240

  Show 175 Study Locations
Sponsors and Collaborators
Synergy Pharmaceuticals Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Synergy Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01982240     History of Changes
Other Study ID Numbers: SP304203-00
Study First Received: November 5, 2013
Last Updated: August 14, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Synergy Pharmaceuticals Inc.:
CIC
Constipation
Chronic Constipation
Synergy
Plecanatide

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014