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Clinical Trial Summary

This study will evaluate the safety and efficacy of Tegaserod in opioid-induced constipation in patients with non-cancer pain.

Patients who enter this study PRIOR to the core study (CHTF919N2201) interim analysis receive the treatment as follows:

Patients will be randomly assigned to receive open label tegaserod 6 mg b.i.d. or tegaserod 12 mg o.d. using an allocation ratio of 1:1.

Patients who enter this study AFTER the core study interim analysis receive the treatment as follows:

Patients will be assigned to receive the selected tegaserod dose regimen (as determined by the core study interim analysis) in an open label fashion.


Clinical Trial Description

n/a


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00414024
Study type Interventional
Source Novartis
Contact
Status Terminated
Phase Phase 3
Start date February 2007
Completion date May 2007

See also
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Terminated NCT01901302 - Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation Phase 3
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Terminated NCT01384292 - Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain Phase 3
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Completed NCT00672139 - Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness Phase 4
Terminated NCT01901341 - The Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation Phase 3
Recruiting NCT03720613 - Risk of Major Adverse Cardiovascular Events for Naldemedine and Other Medications for Opioid Induced Constipation in Adults With Chronic Non-Cancer Pain
Completed NCT01368562 - Compassionate Use Study of Methylnaltrexone N/A
Completed NCT01040637 - A Multiple Dose Study of TD-1211 in Healthy Volunteers and Patients With Opioid-Induced Constipation Phase 1/Phase 2