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NCT00730171·Phase 3·INTERVENTIONAL

An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

LinaclotideOtherCompleted

Status

Completed

Phase

Phase 3

Enrollment

1,743

Locations

116

Results

Posted

Publications

0

Study summary

What the protocol is testing.

The objective of this study is to assess the long-term safety of linaclotide administered to patients with chronic constipation (CC) or irritable bowel syndrome with constipation (IBS-C).

Full detailed description

Participants include randomization-ineligible (RI) patients from the lead-in double-blind trials MCP-103-302 (NCT00938717) or MCP-103-303 (NCT00730015), or rollover (RO) patients from the lead-in double-blind trials MCP-103-302 (NCT00938717), MCP-103-303 (NCT00730015), and from the Phase 2 double-blind studies MCP-103-004 (NCT00306748), MCP-103-005 (NCT00258193), and MCP-103-201 (NCT00402337), or MCP-103-202 (NCT00460811).

Interventions

Treatment arms and agents.

DRUG

Linaclotide

Linaclotide capsules, oral, once daily each morning at least 30 minutes before breakfast for the duration of the study.

Timeline

From registration to results.

  1. First posted

    Aug 8, 2008

  2. Study start

    Sep 2008

  3. Primary completion

    Mar 2012

  4. Study completion

    Mar 2012

  5. Results posted

    Feb 19, 2018

  6. Registry updated

    Feb 19, 2018

Outcomes

What the study measures.

Primary outcomes

Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)

Time frame · From first dose of open-label study drug up to 78 weeks

For RI and Phase 2 RO participants, an AE that occurred during the study was considered a TEAE if it was not present before the day of the first dose of open-label study drug, or was present before the day of the first dose of open-label study drug but increased in severity on or after that day. For Phase 3 RO participants, an AE that occurred during the study was considered a TEAE if it was not present before the day of the first dose of double-blind study drug in trial MCP-103-302 or MCP-103-303, or was present before the day of the first dose of double-blind study drug in those trials but increased in severity on or after that day. Deaths and serious AEs (SAEs) are those that occurred on or after the date of the first dose of open-label study drug, and within 30 days of the date of last dose of open-label study drug.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Patients must have * entered study MCP-103-303 or MCP-103-302 and at minimum completed the pre-treatment period or * completed one of the following studies: MCP-103-004, MCP-103-005, MCP-103-201, MCP-103-202 * Sexually active patients of childbearing potential agree to use birth control * Females of childbearing potential must have a negative urine pregnancy test prior to dosing * Lactating females must agree not to breastfeed * Patient must meet protocol criteria for CC or IBS-C Exclusion Criteria: * Patient must not use protocol-defined prohibited medicine * Patient is planning to receive an investigational drug at any time during the study * Patient has an unresolved adverse events or a clinically significant finding on a physical examination, 12-lead electrocardiogram, or clinical laboratory test

Study locations

116 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Ironwood Investigational Site

Birmingham, Alabama, United States

Ironwood Investigational Site

Huntsville, Alabama, United States

Ironwood Investigational Site

Chandler, Arizona, United States

Ironwood Investigational Site

Phoenix, Arizona, United States

Ironwood Investigational Site

Tucson, Arizona, United States

Ironwood Investigational Site

Tucson, Arizona, United States

Ironwood Investigational Site

Tucson, Arizona, United States

Ironwood Investigational Site

Sherwood, Arkansas, United States

Ironwood Investigational Site

Anaheim, California, United States

Ironwood Investigational Site

Chula Vista, California, United States

Ironwood Investigational Site

Encinitas, California, United States

Ironwood Investigational Site

Garden Grove, California, United States

Ironwood Investigational Site

Laguna Hills, California, United States

Ironwood Investigational Site

Los Angeles, California, United States

Ironwood Investigational Site

Orange, California, United States

Ironwood Investigational Site

Sacramento, California, United States

Ironwood Investigational Site

San Carlos, California, United States

Ironwood Investigational Site

San Diego, California, United States

Ironwood Investigational Site

San Diego, California, United States

Ironwood Investigational Site

San Diego, California, United States

Ironwood Investigational Site

Colorado Springs, Colorado, United States

Ironwood Investigational Site

Bristol, Connecticut, United States

Ironwood Investigational Site

Boynton Beach, Florida, United States

Ironwood Investigational Site

Hollywood, Florida, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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