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NCT00948818 · ClinicalTrials.gov registry record · Phase 3

Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation

A Phase 3 study, sponsored by Forest Laboratories.

Completed
Registry status
Phase 3
Development phase
803
Enrollment target

NCT00948818 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 803 participants.

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The verdict

NCT00948818, a Phase 3 study, has completed, sponsored by Forest Laboratories.

COMPLETED
Registry status
Phase 3
Development phase
803 participants
Enrollment target

Study Summary

The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with irritable bowel syndrome with constipation (IBS-C). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder.

Interventions

  • DRUG Matching placebo
  • DRUG Linaclotide 290 micrograms

Trial Details

FieldValue
Enrollment Target 803 participants
Start Date 2009-07
Est. Completion 2010-08
Phase Phase 3

Sponsor

Forest Laboratories

145 total trials

What the Registry Record Tells You About NCT00948818

The ClinicalTrials.gov registry entry for NCT00948818 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 803 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 2 interventions - of which Matching placebo is the first listed.

NCT00948818 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00948818 about?

NCT00948818 is a clinical study titled "Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation". The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with irritable bowel syndrome with constipation (IBS-C). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Abdominal P...

What is the current status of trial NCT00948818?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 803 participants. The study started on 2009-07. Estimated completion is 2010-08.

What interventions are being tested in trial NCT00948818?

The interventions under investigation include: Matching placebo (DRUG), Linaclotide 290 micrograms (DRUG).

Who is sponsoring clinical trial NCT00948818?

This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.