Clinical trial · Interventional
Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.
An Open Label 52-week Study to Evaluate the Safety and Efficacy of Tegaserod Given Orally for the Treatment of Opioid-induced Constipation (OIC) in Patients With Chronic Non-cancer Pain
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This study was terminated early as a result of regulatory action suspending tegaserod use in 2007
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Opioid-induced Constipation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tegaserod | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To evaluate the long term safety of tegaserod
Secondary outcomes (3)
- measure
- Change from baseline assessment of OIC symptoms at weeks 24 and 52
- measure
- Change from baseline assessment of opioid-induced mid/upper GI symptoms at weeks 24 and 52
- measure
- Patients weekly assessment of intensity of pain for which opioids were prescribed at weeks 24 and 52
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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. * 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: 1. Hard or very hard stools 2. sensation of incomplete evacuation 3. straining while having a bowel movement Exclusion Criteria: * 1\. Who are receiving opioids for abdominal pain or connective tissue disorders. * Planned discontinuation of opioids during the study * Who underwent major surgery within 3 months prior to screening. * With a history of prior chronic constipation (CC) that was present for more than three months and that was not related to opioid use. * With a current diagnosis of irritable bowel syndrome (IBS) constipation predominant or alternators. * With a previous use of tegaserod within 3 months prior to baseline. Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
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