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COMPLETED Phase 3

Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation

NCT00765882 · View on ClinicalTrials.gov ↗

Study Summary

The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Linaclotide 290 micrograms
  • DRUG Linaclotide 145 micrograms

Study Locations (20)

Arizona

  • Forest Investigative Site — Chandler
  • Forest Investigative Site — Mesa
  • Forest Investigative Site — Peoria
  • Forest Investigative Site — Phoenix
  • Forest Investigative Site — Scottsdale
  • Forest Investigative Site — Tucson

California

  • Forest Investigative Site — Burbank
  • Forest Investigative Site — Encinitas
  • Forest Investigative Site — Foothill Ranch
  • Forest Investigative Site — Los Angeles
  • Forest Investigative Site — Orange
  • Forest Investigative Site — Westlake Village

Colorado

  • Forest Investigative Site — Boulder
  • Forest Investigative Site — Colorado Springs
  • Forest Investigative Sites — Denver
  • Forest Investigative Site — Longmont
  • Forest Investigative Site — Wheat Ridge

Alabama

  • Forest Investigative Site — Birmingham
  • Forest Investigative Site — Birmingham
  • Forest Investigative Site — Huntsville

Trial Details

FieldValue
Enrollment Target 633 participants
Start Date 2008-09
Est. Completion 2009-08
Phase Phase 3

Sponsor

Forest Laboratories

32 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00765882

The ClinicalTrials.gov registry entry for NCT00765882 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 633 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forest Laboratories, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Chronic Constipation appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00765882 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Arizona, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00765882 about?

NCT00765882 is a clinical study titled "Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation". The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Complete Spontaneous Bowel Movement (...

What is the current status of trial NCT00765882?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 633 participants. The study started on 2008-09. Estimated completion is 2009-08.

What conditions does trial NCT00765882 study?

This clinical trial studies the following conditions: Chronic Constipation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00765882?

The interventions under investigation include: Placebo (DRUG), Linaclotide 290 micrograms (DRUG), Linaclotide 145 micrograms (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00765882?

This trial is sponsored by Forest Laboratories, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00765882 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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