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Trial record 2 of 8 for:    plecanatide

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

This study has been completed.
Information provided by (Responsible Party):
Synergy Pharmaceuticals Inc. Identifier:
First received: April 22, 2014
Last updated: April 26, 2016
Last verified: April 2016
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 National, 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

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 Complete Spontaneous Bowel Movements (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.

Enrollment: 1410
Study Start Date: April 2014
Study Completion Date: July 2015
Primary Completion Date: May 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 national, 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. 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.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 American Gastroenterological Association (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 Bowel Movements (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 myocardial infarction (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 identifier: NCT02122471

  Show 168 Study Locations
Sponsors and Collaborators
Synergy Pharmaceuticals Inc.
Study Director: Mary Beth Layton Synergy Pharmaceuticals Inc.
  More Information

Responsible Party: Synergy Pharmaceuticals Inc. Identifier: NCT02122471     History of Changes
Other Study ID Numbers: SP304203-03 
Study First Received: April 22, 2014
Last Updated: April 26, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Synergy Pharmaceuticals Inc.:
Chronic Constipation

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms processed this record on October 20, 2016