Efficacy and Safety of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain
Constipation
About this trial
This is an interventional treatment trial for Constipation focused on measuring Opioid, constipation, tegaserod, Opioid-induced constipation
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Sites / Locations
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- Novartis Pharmaceutical Corporation
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