Efficacy and Safety of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain

Stopped early · Phase 2/Phase 3

Conditions studied: Constipation

In brief

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

Key facts

Study ID

NCT00365820

Run by

Novartis

People needed

670

Starts

2006-07-01

Expected to finish

2007-04-01

Last updated by the study team

2012-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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. 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.
• 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

You may not qualify if…

• Patients who are receiving opioids for abdominal pain or connective tissue disorders.
• Planned discontinuation or an increase or decrease by more than 30% of the current opioid dose
• Patients who underwent major surgery within 3 months prior to screening.
• 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.
• Patients with a current diagnosis of irritable bowel syndrome (IBS) constipation predominant or alternators.
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Investigative Site — Phoenix, Arizona, United States
• Investigative Site — Phoenix, Arizona, United States
• Investigative Site — Tucson, Arizona, United States
• Investigative Site — North Little Rock, Arkansas, United States
• Investigative Site — Buena Park, California, United States
• Investigative Site — Downey, California, United States
• Investigative Site — Encinitas, California, United States
• Investigative Site — Fountain Valley, California, United States
• Investigative Site — La Jolla, California, United States
• Investigative Site — Los Angeles, California, United States
• Investigative Site — Mission Viejo, California, United States
• Investigative Site — San Diego, California, United States
• Investigative Site — San Francisco, California, United States
• Investigative Site — Torrance, California, United States
• Investigative Site — Northglenn, Colorado, United States
• Investigative Site — Bristol, Connecticut, United States
• Investigative Site — DeLand, Florida, United States
• Investigative Site — Jacksonville, Florida, United States
• Investigative Site — Largo, Florida, United States
• Investigative Site — Miami, Florida, United States
• Investigative Site — New Smyrna Beach, Florida, United States
• Investigative Site — Springhill, Florida, United States
• Investigative Site — Tampa, Florida, United States
• Investigative Site — Belleville, Illinois, United States
• Investigative Site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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