Clinical trial · Interventional
Efficacy and Safety of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain
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
- 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 efficacy and safety of tegaserod in opioid-induced constipation in patients with non-cancer pain.
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 |
|---|---|---|---|
| Constipation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tegaserod | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Change from baseline in the number of bowel movements over weeks 1-4
Secondary outcomes (3)
- measure
- Change from baseline in the number of bowel movements over weeks 1-12
- measure
- Change from baseline in abdominal distension/bloating over weeks 1-12
- measure
- Change from baseline in abdominal discomfort/pain over weeks 1-12
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.References
Publications (0)
Data not yet available