A Phase 2/3 interventional study of plecanatide and Placebo in Chronic Idiopathic Constipation, sponsored by Bausch Health Americas, Inc.. Completed at 121 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-05-28.
Sponsored by Bausch Health Americas, Inc. · Phase 2/3, Interventional, and Treatment
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).
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.
1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's enrollment of 951 is above the median of 80 across 850 interventional studies indexed under Constipation.
Browse Constipation studies →Bausch Health Americas, Inc. is the lead sponsor of 209 studies on the registry; 9 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects receive plecanatide 0.3 mg for 12 consecutive weeks
Drug: plecanatide
Subjects receive plecanatide 1.0 mg for 12 consecutive weeks
Drug: plecanatide
Subjects receive plecanatide 3.0 mg for 12 consecutive weeks
Drug: plecanatide
Subjects receive placebo for 12 consecutive weeks
Other: Placebo
Subjects receive experimental study drug for 12 weeks.
Also known as: Trulance
Subjects receive experimental study drug for 12 weeks.
Overall Responder 9/12 Weeks
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.
Time frame: 12-Week Treatment Period
Change From Baseline in 12-week CSBM Weekly Frequency Rate
The number of Complete Spontaneous Bowel Movements (CSBMs) per week
Time frame: 12-Week Treatment Period
Change From Baseline in 12-week SBM Weekly Frequency Rate
The number of Spontaneous Bowl Movements experienced per week.
Time frame: 12-Week Treatment Period
Change From Baseline in Stool Consistency (BSFS) to Over 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. 1. = separate hard lumps like nuts (difficult to pass) 2. = sausage shaped but lumpy 3. = like a sausage but with cracks on its surface 4. = like a sausage or snake, smooth and soft 5. = soft blobs with clear-cut edges (passed easily) 6. = fluffy pieces with ragged edges, a mushy stool 7. = watery, no solid pieces (entirely liquid)
Time frame: 12-Week Treatment Period
Change From Baseline in 12-week Patient Reported Symptoms Associated With Constipation - Straining Score
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
Time frame: 12-Week Treatment Period
| Milestone | Plecanatide 0.3 mg | Plecanatide 1.0 mg | Plecanatide 3.0 mg | Placebo |
|---|---|---|---|---|
| Started | 238 | 238 | 238 | 237 |
| Completed | 189 | 176 | 202 | 171 |
| Not completed | 49 | 62 | 36 | 66 |
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.
| % of Overall Responder 9/12 weeks | Plecanatide 0.3 mg | Plecanatide 1.0 mg | Plecanatide 3.0 mg | Placebo |
|---|---|---|---|---|
| Overall Responder 9/12 Weeks | 18.6 | 16.8 | 19.0 | 10.7 |
The number of Complete Spontaneous Bowel Movements (CSBMs) per week
| CSBMs per week | Plecanatide 0.3 mg | Plecanatide 1.0 mg | Plecanatide 3.0 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in 12-week CSBM Weekly Frequency Rate | 1.60 ± 0.159 | 1.81 ± 0.157 | 2.18 ± 0.159 | 1.09 ± 0.162 |
The number of Spontaneous Bowl Movements experienced per week.
| SBMs per week | Plecanatide 0.3 mg | Plecanatide 1.0 mg | Plecanatide 3.0 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in 12-week SBM Weekly Frequency Rate | 2.20 ± 0.190 | 2.38 ± 0.188 | 3.00 ± 0.191 | 1.35 ± 0.194 |
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. 1. = separate hard lumps like nuts (difficult to pass) 2. = sausage shaped but lumpy 3. = like a sausage but with cracks on its surface 4. = like a sausage or snake, smooth and soft 5. = soft blobs with clear-cut edges (passed easily) 6. = fluffy pieces with ragged edges, a mushy stool 7. = watery, no solid pieces (entirely liquid)
| scores on a scale | Plecanatide 0.3 mg | Plecanatide 1.0 mg | Plecanatide 3.0 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in Stool Consistency (BSFS) to Over Treatment Period | 1.28 ± 0.090 | 1.70 ± 0.090 | 1.97 ± 0.089 | 0.87 ± 0.091 |
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
| scores on a scale | Plecanatide 0.3 mg | Plecanatide 1.0 mg | Plecanatide 3.0 mg | Placebo |
|---|---|---|---|---|
| Change From Baseline in 12-week Patient Reported Symptoms Associated With Constipation - Straining Score | -1.25 ± 0.142 | -1.46 ± 0.142 | -1.73 ± 0.143 | -1.04 ± 0.144 |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Plecanatide 0.3 mg | — | 1/237 (0.4%) | 55/237 (23.2%) |
| Plecanatide 1.0 mg | — | 1/238 (0.4%) | 79/238 (33.2%) |
| Plecanatide 3.0 mg | — | 2/237 (0.8%) | 92/237 (38.8%) |
| Placebo | — | 5/236 (2.1%) | 45/236 (19.1%) |
| Event | Plecanatide 0.3 mg | Plecanatide 1.0 mg | Plecanatide 3.0 mg | Placebo |
|---|---|---|---|---|
| Non-cardiac chest painGeneral disorders | 1/237 | 0/238 | 0/237 | 1/236 |
| GastroenteritisInfections and infestations | 0/237 | 0/238 | 0/237 | 1/236 |
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 0/237 | 0/238 | 0/237 | 1/236 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/237 | 0/238 | 0/237 | 1/236 |
| HypertensionVascular disorders | 0/237 | 0/238 | 0/237 | 1/236 |
| AstheniaGeneral disorders | 0/237 | 0/238 | 1/237 | 0/236 |
| Cholecystitis AcuteHepatobiliary disorders | 0/237 | 0/238 | 1/237 | 0/236 |
| HypoaesthesiaNervous system disorders | 0/237 | 0/238 | 1/237 | 0/236 |
| EndometriosisReproductive system and breast disorders | 0/237 | 1/238 | 0/237 | 0/236 |
| Event | Plecanatide 0.3 mg | Plecanatide 1.0 mg | Plecanatide 3.0 mg | Placebo |
|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 13/237 | 20/238 | 23/237 | 3/236 |
| FlatulenceGastrointestinal disorders | 5/237 | 3/238 | 14/237 | 5/236 |
| Abdominal PainGastrointestinal disorders | 6/237 | 9/238 | 12/237 | 11/236 |
| NauseaGastrointestinal disorders | 5/237 | 12/238 | 8/237 | 5/236 |
| HeadacheNervous system disorders | 10/237 | 11/238 | 9/237 | 5/236 |
| Abdominal DistensionGastrointestinal disorders | 5/237 | 10/238 | 9/237 | 5/236 |
| Upper Respiratory tract infectionInfections and infestations | 6/237 | 5/238 | 9/237 | 5/236 |
| Urinary Tract InfectionInfections and infestations | 5/237 | 9/238 | 8/237 | 6/236 |
The mITT population included all randomized patients who received ≥ 1 dose of study drug and ≥ 1 post-baseline BM assessment. 951 patients were randomized; 3 were not treated and 2 received study drug but did not complete a post-dose assessment, yielding 946 patients in the mITT population.
| Age, Continuous(years) | Plecanatide 0.3 mg | Plecanatide 1.0 mg | Plecanatide 3.0 mg | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 47.8 (20 to 75) | 47.1 (18 to 75) | 47.1 (18 to 75) | 46.3 (19 to 75) | 47.1 (18 to 75) |
| Sex: Female, Male(Participants) | Plecanatide 0.3 mg | Plecanatide 1.0 mg | Plecanatide 3.0 mg | Placebo | Total |
|---|---|---|---|---|---|
| Female | 203 | 202 | 205 | 207 | 817 |
| Male | 34 | 36 | 32 | 27 | 129 |
Showing the first 100 of 121 sites.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Bausch Health Americas, Inc.