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NCT00730015 · ClinicalTrials.gov registry record · Phase 3

Trial of Linaclotide in Patients With Chronic Constipation

A Phase 3 study of Chronic Constipation, sponsored by Ironwood Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
643
Enrollment target
20
Study locations

NCT00730015 is a Phase 3 study of Chronic Constipation that has completed, run by Ironwood Pharmaceuticals. The registered enrollment target is 643 participants, roughly in line with the 632-participant average among 4 other Chronic Constipation trials with a reported enrollment target. The trial reports 20 study locations across 5 states.

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The verdict

NCT00730015, a Phase 3 study of Chronic Constipation, has completed, sponsored by Ironwood Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
643 participants
Enrollment target
20
Study locations

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 dosing group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder.

Conditions Studied

Chronic Constipation

Interventions

  • DRUG Matching Placebo
  • DRUG Linaclotide

Study Locations (20)

California

  • Ironwood Investigational Site - Anaheim
  • Ironwood Investigational Site - Chula Vista
  • Ironwood Investigational Site - Encinitas
  • Ironwood Investigational Site - Garden Grove
  • Ironwood Investigational Site - Laguna Hills
  • Ironwood Investigational Site - Los Angeles
  • Ironwood Investigational Site - Orange
  • Ironwood Investigational Site - Sacramento
  • Ironwood Investigational Site - San Carlos
  • Ironwood Investigational Site - San Diego
  • Ironwood Investigational Site - San Diego
  • Ironwood Investigational Site - San Diego

Arizona

  • Ironwood Investigational Site - Chandler
  • Ironwood Investigational Site - Phoenix
  • Ironwood Investigational Site - Tucson
  • Ironwood Investigational Site - Tuscon

Alabama

  • Ironwood Investigational Site - Birmingham
  • Ironwood Investigational Site - Huntsville

Arkansas

  • Ironwood Investigational Site - Sherwood

Colorado

  • Ironwood Investigational Site - Colorado Springs

Trial Details

FieldValue
Enrollment Target 643 participants
Start Date 2008-08
Est. Completion 2009-10
Phase Phase 3

Sponsor

Ironwood Pharmaceuticals

23 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00730015

The ClinicalTrials.gov registry entry for NCT00730015 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 643 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 632-participant average among 4 other Chronic Constipation trials with a reported enrollment target. The listed sponsor is Ironwood Pharmaceuticals, which has 23 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Chronic Constipation appearing as the primary indexed condition, and to 2 interventions - of which Matching Placebo is the first listed.

NCT00730015 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Arizona, Alabama.

Frequently Asked Questions

What is clinical trial NCT00730015 about?

NCT00730015 is a clinical study titled "Trial of Linaclotide in 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 dosing group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSB...

What is the current status of trial NCT00730015?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 643 participants. The study started on 2008-08. Estimated completion is 2009-10.

What conditions does trial NCT00730015 study?

This clinical trial studies the following conditions: Chronic Constipation.

What interventions are being tested in trial NCT00730015?

The interventions under investigation include: Matching Placebo (DRUG), Linaclotide (DRUG).

Who is sponsoring clinical trial NCT00730015?

This trial is sponsored by Ironwood Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00730015 being conducted?

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

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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.