Long Term Safety Study of Plecanatide (IBS-C)
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|ClinicalTrials.gov Identifier: NCT02706483|
Recruitment Status : Completed
First Posted : March 11, 2016
Last Update Posted : October 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome||Drug: Plecanatide||Phase 3|
This is a phase 3, multicenter, open-label, long-term safety and tolerability study of 6 mg daily dose of plecanatide administered orally. Patients who are Study Completers or Eligible Screen Failures whose eligibility is confirmed at the end of their participation in the double-blind plecanatide studies SP304203-04 or SP304203-05 will be enrolled.
Beginning on Day 1, patients will take one (1) plecanatide 6.0 mg tablet in the clinic and thereafter every morning with approximately 240 mL (8 ounces) of liquid, with or without meals.
Safety and tolerability assessments and patients' self-assessment of disease severity will be performed according to the Schedule of Assessments.
Patients who discontinue early from the study will undergo an Early Withdrawal (EW) visit within 5 days after stopping study drug.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Long Term Safety and Tolerability Study of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)|
|Study Start Date :||January 2016|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||June 2017|
Plecanatide 6.0 mg tablets
- Number of participants with treatment related adverse events. [ Time Frame: up to 53 weeks ]
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): NCT02706483
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