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: NCT00765999|
Recruitment Status : Completed
First Posted : October 3, 2008
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Constipation Irritable Bowel Syndrome With Constipation||Drug: Linaclotide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1559 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|
|Actual Study Start Date :||October 31, 2008|
|Actual Primary Completion Date :||January 31, 2012|
|Actual Study Completion Date :||January 31, 2012|
Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks in participants with either CC or IBS-C. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator if a participant experienced AEs intolerable enough to prompt consideration of study withdrawal. After a temporary suspension of dosing, participants may have received either 145 μg/day or 290 μg/day of linaclotide, at the discretion of the Investigator. Subsequent dose adjustments (increases or decreases between 290 μg/day and 145 μg/day) were permitted also at the Investigator's discretion.
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 Events (TEAEs) [ Time Frame: Up to 78 weeks for AEs; within 30 days of last dose of study drug (up to 82 weeks) for serious AEs. ]An AE is any untoward medical occurrence in a clinical study participant administered study drug. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the medicinal product. An AE that occurred during the treatment period was defined as a TEAE if the AE was either not present at, or before, the day of the first dose of open-label study medication in this study or was present at, or before, the day of the first dose of open-label study medication in this study and increased in severity during the treatment period. AEs included abnormal clinically significant findings for clinical laboratory tests, physical examination findings, vital sign measurements and electrocardiograms (ECGs).
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): NCT00765999
|Study Director:||Paul Eng, PhD||Forest Laboratories|