Phase 3
Completed N=1,337
12-Week Study of Plecanatide for CIC (The National CIC3 Study)
Chronic Idiopathic Constipation
Source: ClinicalTrials.gov NCT02122471 ↗
Enrolled (actual)
1,337
Serious AEs
1.4%
Results posted
Mar 2019
Primary outcomePrimary: Number of Durable Overall CSBM Responders, Mean Replacement Approach — 57; 88; 88 Participants
◆ Published Evidence
Established
75citations · ~8 / year
Randomized clinical trial: efficacy and safety of plecanatide in the treatment of chronic idiopathic constipation.
Summary
The purpose of this study is to confirm that the investigational medication, plecanatide, is safe and effective in treating chronic idiopathic constipation.
Linked Publications (4)
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Randomized clinical trial: efficacy and safety of plecanatide in the treatment of chronic idiopathic constipation.
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Evaluation of Plecanatide for the Treatment of Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation in Patients 65 Years or Older.
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Plecanatide for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation: Post hoc analyses of placebo-controlled trials in adults with severe constipation.
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The Effect of Acid Suppression Therapy on the Safety and Efficacy of Plecanatide: Analysis of Randomized Phase III Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Durable Overall CSBM Responders, Mean Replacement Approach |
57; 88; 88 | — |
| SECONDARY Change From Baseline in CSBMs (CSBMs/Week) Over the 12-week Treatment Period , Mean Replacement Approach |
1.41; 2.34; 2.19; 1.69; 2.66; 2.50 | — |
| SECONDARY Change From Baseline in SBMs (SBMs/Week) Over the 12-week Treatment Period, Mean Replacement Approach |
1.55; 1.79; 1.63; 1.81; 3.25; 3.10 | — |
| SECONDARY Change From Baseline in Average Weekly SBM Stool Consistency Over the 12-week Treatment Period, Mean Replacement Approach |
2.35; 2.16; 2.27; 1.02; 1.71; 1.59 | — |
| SECONDARY Change From Baseline in Average Weekly Straining Score Over the 12-week Treatment Period, Mean Replacement Approach |
2.42; 2.46; 2.47; -0.79; -1.09; -1.04 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02122471) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.