An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
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|ClinicalTrials.gov Identifier: NCT00730171|
Recruitment Status : Completed
First Posted : August 8, 2008
Results First Posted : February 16, 2018
Last Update Posted : February 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome With Constipation Chronic Constipation||Drug: Linaclotide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1743 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Long-term Safety Study of Oral Linaclotide Administered to Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
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.
Linaclotide capsules, oral, once daily each morning at least 30 minutes before breakfast for the duration of the study.
Other Name: Linzess
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00730171
Show 116 Study Locations
|Study Chair:||Jeffrey M. Johnston, MD, FACP||Ironwood Pharmaceuticals, Inc.|