The Plecanatide Chronic Idiopathic Constipation (CIC) Study
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01429987 |
Recruitment Status :
Completed
First Posted : September 7, 2011
Results First Posted : November 29, 2017
Last Update Posted : May 28, 2019
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Idiopathic Constipation | Drug: plecanatide Other: Placebo | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 951 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
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.
Other Name: Trulance |
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.
Other Name: Trulance |
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.
Other Name: Trulance |
Placebo Comparator: Placebo
Subjects receive placebo for 12 consecutive weeks
|
Other: Placebo
Subjects receive experimental study drug for 12 weeks. |
- Overall Responder 9/12 Weeks [ Time Frame: 12-Week Treatment Period ]A Complete Spontaneous Bowel Movement (CSBM) is a Bowel Movement (BM) that occurs in the absence of laxative use within 24 hours of the BM 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 in the same week. An overall responder is a patient who is a weekly responder for at least 9 of the 12 treatment weeks, including at least 3 of the last 4 weeks.
- Change From Baseline in 12-week CSBM Weekly Frequency Rate [ Time Frame: 12-Week Treatment Period ]The number of Complete Spontaneous Bowel Movements (CSBMs) per week
- Change From Baseline in 12-week SBM Weekly Frequency Rate [ Time Frame: 12-Week Treatment Period ]The number of Spontaneous Bowl Movements experienced per week.
- Change From Baseline in Stool Consistency (BSFS) to Over Treatment Period [ Time Frame: 12-Week Treatment Period ]
The stool consistency of each bowel movement (BM) was assessed by patients using the 7-point Bristol Stool Form Scale [BSFS] from 1 to 7.
- = separate hard lumps like nuts (difficult to pass)
- = sausage shaped but lumpy
- = like a sausage but with cracks on its surface
- = like a sausage or snake, smooth and soft
- = soft blobs with clear-cut edges (passed easily)
- = fluffy pieces with ragged edges, a mushy stool
- = watery, no solid pieces (entirely liquid)
- Change From Baseline in 12-week Patient Reported Symptoms Associated With Constipation - Straining Score [ Time Frame: 12-Week Treatment Period ]The severity of straining (Straining Score) was reported by the patients using a 11-point scale (0-10) where 0 = none and 10 = the worst

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01429987

Responsible Party: | Bausch Health Americas, Inc. |
ClinicalTrials.gov Identifier: | NCT01429987 |
Other Study ID Numbers: |
SP304-20210 SP-SP30420210 |
First Posted: | September 7, 2011 Key Record Dates |
Results First Posted: | November 29, 2017 |
Last Update Posted: | May 28, 2019 |
Last Verified: | May 2019 |
Chronic Idiopathic Constipation Constipation Sign and Symptoms: Digestive |
Constipation Signs and Symptoms, Digestive Plecanatide Guanylyl Cyclase C Agonists |
Enzyme Activators Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents |