Status:
TERMINATED
Efficacy and Safety of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain
Lead Sponsor:
Novartis
Conditions:
Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This study will evaluate the efficacy and safety of tegaserod in opioid-induced constipation in patients with non-cancer pain.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
670 Patients enrolled
Trial Details
Trial ID
NCT00365820
Start Date
July 1 2006
End Date
April 1 2007
Last Update
April 20 2012
Active Locations (59)
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1
Investigative Site
Mobile, Alabama, United States, 36608
2
Investigative Site
Phoenix, Arizona, United States, 85029
3
Investigative Site
Phoenix, Arizona, United States, 85050
4
Investigative Site
Tucson, Arizona, United States, 85712