Efficacy and Safety of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain (NCT00365820) | Clinical Trial Compass
TerminatedPhase 2/3
Efficacy and Safety of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain
Stopped: This study was terminated early as a result of regulatory action suspending tegaserod use in 2007
United States670 participantsStarted 2006-07
Plain-language summary
This study will evaluate the efficacy and safety of tegaserod in opioid-induced constipation in patients with non-cancer pain.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
✓. 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.
✕
What they're measuring
1
Change from baseline in the number of bowel movements over weeks 1-4