Constipation
Conditions
Keywords
Opioid, constipation, tegaserod, Opioid-induced constipation
Brief summary
This study will evaluate the efficacy and safety of tegaserod in opioid-induced constipation in patients with non-cancer pain.
Interventions
DRUGTegaserod
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the number of bowel movements over weeks 1-4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed