Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opioid-induced Constipation
Intervention: Tegaserod (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Novartis Official(s) and/or principal investigator(s): Novartis Pharmaceuticals Corp., Principal Investigator, Affiliation: NPC
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) 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.
Clinical Details
Official title: 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
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To evaluate the long term safety of tegaserod
Secondary outcome: Change from baseline assessment of OIC symptoms at weeks 24 and 52Change from baseline assessment of opioid-induced mid/upper GI symptoms at weeks 24 and 52 Patients weekly assessment of intensity of pain for which opioids were prescribed at weeks 24 and 52
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
2 Investigative Sites, Hong Kong, China
6 Investigative Sites, Egypt, Egypt
1 Investigative Site, Singapore, Singapore
2 Investigative Sites, Taiwan, Taiwan
4 Investigative Sites, Venezuela, Venezuela
60 Investigative Sites, East Hanover, New Jersey, United States
Additional Information
Starting date: February 2007
Last updated: April 19, 2012
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