Status:
TERMINATED
Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.
Lead Sponsor:
Novartis
Conditions:
Opioid-induced Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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) int...
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.
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00414024
Start Date
February 1 2007
End Date
May 1 2007
Last Update
April 20 2012
Active Locations (6)
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1
60 Investigative Sites
East Hanover, New Jersey, United States
2
2 Investigative Sites
Hong Kong, China
3
6 Investigative Sites
Egypt, Egypt
4
1 Investigative Site
Singapore, Singapore