Prevention of opioid-induced constipation in patients with advanced cancer
- Conditions
- Opioid-induced constipation in patients with advanced cancer, starting with opioids for painMedDRA version: 24.0Level: LLTClassification code 10071128Term: Opioid induced constipationSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2022-000408-36-NL
- Lead Sponsor
- ZonMw
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 330
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•Patients with advanced cancer (=18 years);
•Starting with slow release or transdermal opioids for pain;
•Able to complete a Dutch questionnaire.
Previous treatment with opioids is allowed, if discontinued more than 4 weeks ago
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 220
A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Patients with contra-indications for laxatives
•Maintenance treatment with laxatives during the last two weeks
•Severely impaired renal function (serum creatinine >180 umol/l)
•Estimated life expectancy <1 month
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method