Prevention of constipation during treatment with opioids: magnesiumoxide versus macrogol/elektrolytes
Phase 3
Completed
- Conditions
- Constipation/difficulty with bowel movements10017977
- Registration Number
- NL-OMON33671
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 155
Inclusion Criteria
Palliative care cancer patients starting with opioids
Age >18 years
Exclusion Criteria
Contra-indication for laxative use
Use of laxatives up to 4 weeks before entry in the study
Serum creatinine >180 ug/l
Estimated life expectancy <3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint:<br /><br>Degree of constipation as defined by the total score of the Patient Assessment<br /><br>of Constipation-Symptom (PAC SYM;constipation symptom assessment instrument)<br /><br>after 2 weeks of treatment.<br /><br><br /><br>The PAC SYM is an instrument to measure the degree and symptoms of constipation<br /><br>during the previous week. It contains 12 items scored by the patient on a<br /><br>5-point Likert scale. The scores can be calculated en give insight in 3<br /><br>domains: symptoms of defaecation, rectal symptoms and abdominal symptoms. The<br /><br>instrument has been validated for patients with chronic functional constipation<br /><br>and for patients using opioids for chronic back pain. In the last study a Dutch<br /><br>version has been used.</p><br>
- Secondary Outcome Measures
Name Time Method