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

NCTNCT00730171Other idMCP-103-305

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 1,743 participants (actual)
Sponsor: Ironwood Pharmaceuticals, Inc. · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: Sept 2008
Primary completion: Mar 2012
Completion: Mar 2012
First posted: 8 Aug 2008 (estimated)
Last update posted: 19 Feb 2018
Conditions: Irritable Bowel Syndrome With Constipation · Chronic Constipation

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200820092010201120122013

Ph 3
An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
NCT00730171
Sept 2008 to Mar 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

LinaclotideDrug

Arms1

Experimental
Linaclotide
Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator.

Primary outcomes1

Outcomes the sponsor listed as primary.

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
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· From first dose of open-label study drug up to 78 weeks

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

Group	Value (Participants)
CC Safety Population: Total	65
IBS-C Safety Population: Total	389
Overall Safety Population: Total	454

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
CC Safety Population: TotalRI and RO participants who met the modified Rome II criteria for CC and who received linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator.	2 / 607	41 / 607	283 / 607
IBS-C Safety Population: TotalRI and RO participants who met the modified Rome II criteria for IBS-C and who received linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator.	2 / 1119	56 / 1119	572 / 1119
Overall Safety Population: TotalAll RI and RO participants who received linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator.	4 / 1725	97 / 1725	855 / 1725

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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