Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.
This study has been terminated.
(This study was terminated early as a result of regulatory action suspending tegaserod use in 2007)
Sponsor:
Novartis
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00414024
First received: December 19, 2006
Last updated: April 19, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Opioid-induced Constipation |
Drug: Tegaserod |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Constipation
Drug Information available for:
Tegaserod maleate
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- To evaluate the long term safety of tegaserod
Secondary Outcome Measures:
- Change from baseline assessment of OIC symptoms at weeks 24 and 52
- Change 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
| Enrollment: | 11 |
| Study Start Date: | February 2007 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | 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:
- Hard or very hard stools
- sensation of incomplete evacuation
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00414024
Locations
| United States, New Jersey | |
| 60 Investigative Sites | |
| East Hanover, New Jersey, United States | |
| China | |
| 2 Investigative Sites | |
| Hong Kong, China | |
| Egypt | |
| 6 Investigative Sites | |
| Egypt, Egypt | |
| Singapore | |
| 1 Investigative Site | |
| Singapore, Singapore | |
| Taiwan | |
| 2 Investigative Sites | |
| Taiwan, Taiwan | |
| Venezuela | |
| 4 Investigative Sites | |
| Venezuela, Venezuela | |
Sponsors and Collaborators
Novartis
Investigators
| Principal Investigator: | Novartis Pharmaceuticals Corp. | NPC |
More Information
No publications provided
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00414024 History of Changes |
| Other Study ID Numbers: | CHTF919N2302 |
| Study First Received: | December 19, 2006 |
| Last Updated: | April 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Opioid, constipation, tegaserod |
Additional relevant MeSH terms:
|
Constipation Signs and Symptoms, Digestive Signs and Symptoms Analgesics, Opioid Tegaserod Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013