The Plecanatide Chronic Idiopathic Constipation (CIC) Study - Full Text View

Purpose

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).

Condition	Intervention	Phase
Chronic Idiopathic Constipation	Drug: plecanatide	Phase 2 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:	Study SP304-20210: A Randomized, 12-Week, Double-Blind, Placebo-Controlled, Repeat-Dose, Oral, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients With Chronic Idiopathic Constipation

Resource links provided by NLM:

MedlinePlus related topics: Constipation

U.S. FDA Resources

Further study details as provided by Synergy Pharmaceuticals, Inc.:

Primary Outcome Measures:

Complete Spontaneous Bowel Movement (CSBM) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
A complete spontaneous bowel movement occurs 24 hours away from laxative use and the patient reports a feeling of complete evacuation. A weekly responder will have 3 or more CSBMs and an increase of at least one CSBM from baseline. A monthly responder achieves this for 3 of the 4 weeks in a month. An overall responder must achieve this in 2 of the 3 months of treatment with one of those months being the latest treatment period.

Secondary Outcome Measures:

Reduction in straining and abdominal symptoms such as pain, discomfort and bloating. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
To demonstrate the reduction in straining and abdominal symptoms such as pain, discomfort and bloating as determined via patient reported outcome (PRO) measures collected via an Interactive Voice Response System (IVRS). To demonstrate an improvement in the hardness of stool , the frequency of spontaneous movements, and a reduction in time to first bowel movement. To monitor and report all treatment emergent adverse events.

Enrollment:	951
Study Start Date:	October 2011
Study Completion Date:	December 2012
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: plecanatide 0.3 mg Subjects receive plecanatide 0.3 mg for 12 consecutive weeks	Drug: plecanatide Subjects receive experimental study drug for 12 weeks.
Experimental: plecanatide 1.0 mg Subjects receive plecanatide 1.0 mg for 12 consecutive weeks	Drug: plecanatide Subjects receive experimental study drug for 12 weeks.
Experimental: plecanatide 3.0 mg Subjects receive plecanatide 3.0 mg for 12 consecutive weeks	Drug: plecanatide Subjects receive experimental study drug for 12 weeks.
Experimental: Placebo Subjects receive placebo for 12 consecutive weeks	Drug: plecanatide Subjects receive experimental study drug for 12 weeks.

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 constipation (CIC). Subjects diagnosed with CIC via modified Rome III criteria will be screened against the inclusion and exclusion criteria for the study and enter a 2 Week pre treatment screening. During this phase patients will be required to call in their bowel movements (BM diary) as they occur, and call at least once daily to complete a patient diary of questions on their symptoms (Symptom Diary) associated with CC, as they will throughout the trial. Patients who complete at least 5 days of dosing per week, 6 of each 7 day period of BM diary calls, and continue to have less than 3 complete spontaneous movements per week (as well as meeting other inclusion and exclusion criteria) will be enrolled and randomized to one of three plecanatide doses 0.3 mg, 1.0 mg, and 3.0 mg or placebo. 880 patients will be randomized with the intent of having 200 patients per treatment group (each group the same size) included in efficacy analyses. All subjects receiving at least one dose of plecanatide or matching placebo will be included in the safety analyses.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 /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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01429987

Show 121 Study Locations

Sponsors and Collaborators

Synergy Pharmaceuticals, Inc.

PAREXEL International

More Information

Additional Information:

Sponsor website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Synergy Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01429987 History of Changes
Other Study ID Numbers:	SP304-20210, SP-SP30420210
Study First Received:	September 6, 2011
Last Updated:	May 28, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Synergy Pharmaceuticals, Inc.:

Chronic Idiopathic Constipation
Constipation
Sign and Symptoms: Digestive

Additional relevant MeSH terms:

Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013