This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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)
Information provided by (Responsible Party):
Novartis Identifier:
First received: August 17, 2006
Last updated: April 19, 2012
Last verified: April 2012
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
Intervention Model: Parallel Assignment
Masking: Double
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:

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)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00365820

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

Responsible Party: Novartis Identifier: NCT00365820     History of Changes
Other Study ID Numbers: CHTF919N2201
Study First Received: August 17, 2006
Last Updated: April 19, 2012

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

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017