The Plecanatide Chronic Idiopathic Constipation (CIC) Study
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| ClinicalTrials.gov Identifier: NCT01429987 |
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Recruitment Status :
Completed
First Posted : September 7, 2011
Results First Posted : November 29, 2017
Last Update Posted : May 28, 2019
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Sponsor:
Bausch Health Americas, Inc.
Collaborator:
Parexel
Information provided by (Responsible Party):
Bausch Health Americas, Inc.
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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 Chronic Idiopathic Constipation (CIC).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Idiopathic Constipation | Drug: plecanatide Other: Placebo | Phase 2 Phase 3 |
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.
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Constipation
Drug Information available for:
Plecanatide
| Arm | Intervention/treatment |
|---|---|
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Experimental: plecanatide 0.3 mg
Subjects receive plecanatide 0.3 mg for 12 consecutive weeks
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Drug: plecanatide
Subjects receive experimental study drug for 12 weeks.
Other Name: Trulance |
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Experimental: plecanatide 1.0 mg
Subjects receive plecanatide 1.0 mg for 12 consecutive weeks
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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
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Drug: plecanatide
Subjects receive experimental study drug for 12 weeks.
Other Name: Trulance |
|
Placebo Comparator: Placebo
Subjects receive placebo for 12 consecutive weeks
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Other: Placebo
Subjects receive experimental study drug for 12 weeks. |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
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
Locations
Show 121 study locations
Sponsors and Collaborators
Bausch Health Americas, Inc.
Parexel
Additional Information:
| 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 |
Keywords provided by Bausch Health Americas, Inc.:
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Chronic Idiopathic Constipation Constipation Sign and Symptoms: Digestive |
Additional relevant MeSH terms:
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Constipation Signs and Symptoms, Digestive Plecanatide Guanylyl Cyclase C Agonists |
Enzyme Activators Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents |