Efficacy and Safety of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain
TerminatedPhase 2, Phase 3NCT00365820
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This study will evaluate the efficacy and safety of tegaserod in opioid-induced constipation in patients with non-cancer pain.
Study details
- Official title
- 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
- Conditions
- Interventions
- Sponsor
- Novartis
- Start date
- 2006-07
- Primary completion
- 2007-04
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 59
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Male and female outpatients 18 years of age or older. 2. 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. 3. Chronic pain which has been present for a minimum of 3 months which needs the chronic use of opioids for pain relief. 4. 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: 1. hard or very hard stools 2. sensation of incomplete evacuation 3. straining while having a bowel movement Exclusion Criteria: 1. Patients who are receiving opioids for abdominal pain or connective tissue disorders. 2. Planned discontinuation or an increase or decrease by more than 30% of the current opioid dose 3. Patients who underwent major surgery within 3 months prior to screening. 4. 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. 5. Patients with a current diagnosis of irritable bowel syndrome (IBS) constipation predominant or alternators. Other protocol-defined inclusion/exclusion criteria may apply.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00365820