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NCT01642914 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating
A Phase 3 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 487
- Enrollment target
NCT01642914 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 487 participants.
The verdict
NCT01642914, a Phase 3 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 487 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of linaclotide compared with placebo in patients with chronic constipation (CC) and prominent abdominal bloating. This study includes an up to 3-week screening period and a 2-3 week pretreatment period. Patients who are eligible will be randomized to one of two doses of linaclotide or placebo for 12 weeks. This 12-week study will assess the effects of linaclotide on bowel movement frequency, as well as other abdominal and bowel symptoms of CC.
Interventions
- DRUG Matching placebo
- DRUG Linaclotide 290 micrograms
- DRUG Linaclotide 145 micrograms
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 487 participants |
| Start Date | 2012-08 |
| Est. Completion | 2013-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01642914
The ClinicalTrials.gov registry entry for NCT01642914 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 487 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forest Laboratories, which has 145 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Matching placebo is the first listed.
NCT01642914 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01642914 about?
NCT01642914 is a clinical study titled "Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating". The purpose of this study is to evaluate the efficacy and safety of linaclotide compared with placebo in patients with chronic constipation (CC) and prominent abdominal bloating. This study includes an up to 3-week screening period and a 2-3 week pretreatment period. Patients who are eligible will b...
What is the current status of trial NCT01642914?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 487 participants. The study started on 2012-08. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01642914?
The interventions under investigation include: Matching placebo (DRUG), Linaclotide 290 micrograms (DRUG), Linaclotide 145 micrograms (DRUG).
Who is sponsoring clinical trial NCT01642914?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
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