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Efficacy and Safety 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:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00365820
First received: August 17, 2006
Last updated: April 19, 2012
Last verified: April 2012
History of Changes
  Purpose

This study will evaluate the efficacy and safety of tegaserod in opioid-induced constipation in patients with non-cancer pain.


Condition Intervention Phase
Constipation
 Drug: Tegaserod
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Multicenter Phase II/III Study to Evaluate the Efficacy and Safety of Tegaserod and Placebo Given Orally for 12 Weeks for the Treatment of Opioid-induced Constipation (OIC) in Patients With Chronic Non-cancer Pain

Resource links provided by NLM:

MedlinePlus related topics: Constipation
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in the number of bowel movements over weeks 1-4

Secondary Outcome Measures:
  • Change from baseline in the number of bowel movements over weeks 1-12
  • Change from baseline in abdominal distension/bloating over weeks 1-12
  • Change from baseline in abdominal discomfort/pain over weeks 1-12

Estimated Enrollment: 670
Study Start Date: July 2006
Study Completion Date: April 2007
Primary Completion Date: April 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:

  1. Male and female outpatients 18 years of age or older.
  2. 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.
  3. Chronic pain which has been present for a minimum of 3 months which needs the chronic use of opioids for pain relief.

  4. 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. Patients who are receiving opioids for abdominal pain or connective tissue disorders.
  2. Planned discontinuation or an increase or decrease by more than 30% of the current opioid dose
  3. Patients who underwent major surgery within 3 months prior to screening.
  4. 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.
  5. Patients with a current diagnosis of irritable bowel syndrome (IBS) constipation predominant or alternators.

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00365820

  Show 59 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharma AG Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00365820     History of Changes
Other Study ID Numbers: CHTF919N2201
Study First Received: August 17, 2006
Last Updated: April 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Opioid, constipation, tegaserod
Opioid-induced constipation

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 June 17, 2013