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NCT02590432 · ClinicalTrials.gov registry record · Phase 4
An Open-Label, Long-term Study to Assess the Immunogenicity of LINZESS® (Linaclotide) Administered Orally to Adult Participants With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation
A Phase 4 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 4
- Development phase
- 828
- Enrollment target
NCT02590432: Completed Phase 4 study, sponsored by Forest Laboratories.
NCT02590432 is a Phase 4 study that has completed, run by Forest Laboratories. The registered enrollment target is 828 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (60% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02590432, a Phase 4 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 828 participants
- Enrollment target
Study Summary
The primary objective of this study is to assess the potential of LINZESS® (linaclotide) treatment to induce the development of anti-drug antibodies (ADAs). The secondary objectives are to provide additional evidence supporting the long-term safety and efficacy of linaclotide in adult irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) participants and to evaluate lower doses of linaclotide.
Primary Outcome
Participants who met either of the following criteria: 1) treatment-induced ADA-positive (≥ 1 postbaseline ADA-positive sample) for baseline ADA negative or ADA-undetermined participants or 2) treatment-boosted ADA-positive (≥ 1 postbaseline ADA-positive sample with titer values ≥ 4-fold the baseline titer value) for baseline ADA-positive participants were reported as a ADA positive responder.
Interventions
- DRUG Linaclotide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 828 participants |
| Start Date | 2015-11-01 |
| Est. Completion | 2018-02-05 |
| Phase | Phase 4 |
What the finished NCT02590432 record still lists
NCT02590432 is an interventional study that assigns participants to a tested intervention. The registered 828 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (60% higher).
The record links to 0 conditions, and to 1 intervention - of which Linaclotide is the first listed.
NCT02590432 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02590432 about?
NCT02590432 is a clinical study titled "An Open-Label, Long-term Study to Assess the Immunogenicity of LINZESS® (Linaclotide) Administered Orally to Adult Participants With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation". The primary objective of this study is to assess the potential of LINZESS® (linaclotide) treatment to induce the development of anti-drug antibodies (ADAs). The secondary objectives are to provide additional evidence supporting the long-term safety and efficacy of linaclotide in adult irritable bowe...
What is the current status of trial NCT02590432?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 828 participants. The study started on 2015-11-01. Estimated completion is 2018-02-05.
What interventions are being tested in trial NCT02590432?
The interventions under investigation include: Linaclotide (DRUG).
Who is sponsoring clinical trial NCT02590432?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02590432's enrollment target sits among peer trials
828 93rd of 2000 higher than 1,908 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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