Efficacy and Safety of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain
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ClinicalTrials.gov Identifier: NCT00365820
Recruitment Status :
(This study was terminated early as a result of regulatory action suspending tegaserod use in 2007)
A Randomized, Double-blind, Placebo-controlled Multicenter Phase II/III Study to Evaluate the Efficacy and Safety of Tegaserod and Placebo Given Orally for 12 Weeks for the Treatment of Opioid-induced Constipation (OIC) in Patients With Chronic Non-cancer Pain
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Male and female outpatients 18 years of age or older.
Patients with chronic non-cancer pain that necessitates the use of non-injectable opioid analgesics. The equivalent dose of 300 mg morphine per day is the maximum opioid analgesic dose allowed. In general, patients should be using opioids on a daily basis.
Chronic pain which has been present for a minimum of 3 months which needs the chronic use of opioids for pain relief.
Constipation, according to the investigator's clinical judgment, that is resulting from opioid use for non-cancer chronic pain. Opioid-induced constipation (OIC) is defined as follows:
less than 3 spontaneous bowel movements per week and at least one of the following on at least 25% of occasions:
hard or very hard stools
sensation of incomplete evacuation
straining while having a bowel movement
Patients who are receiving opioids for abdominal pain or connective tissue disorders.
Planned discontinuation or an increase or decrease by more than 30% of the current opioid dose
Patients who underwent major surgery within 3 months prior to screening.
Patients with a history of prior chronic constipation (CC) that was present for more than three months and that was not related to opioid use.
Patients with a current diagnosis of irritable bowel syndrome (IBS) constipation predominant or alternators.
Other protocol-defined inclusion/exclusion criteria may apply.