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OMAMA
NCT05216328Phase 4
Key facts
- Status
- Recruiting
- Start
- Dec 2022
- Primary completion
- Jan 2027
- Countries
- 1
- Sponsor
- Amsterdam University Medical Center
- Modality
- DNA Intercalators/Alkylators
- Drugs
- Magnesium hydroxide
- Conditions
- opioid-induced constipation (OIC)
01
Overview
Phase 4, randomised, open-label trial of Magnesium hydroxide in opioid-induced constipation (OIC) (2 arms), sponsored by Amsterdam University Medical Center. Primary endpoint: Bowel Function Index score <30 at 14 days. Started Dec 2022; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Macrogol/electrolytes
Macrogol/electrolytes started at 1 sachet once a day orally, may be increased to 2 sachets a day.
Magnesium hydroxide
Magnesium hydroxide started at 724 mg three times a day orally, may be increased to 1448 mg three times a day.
03
Who it enrols
Adult patients with advanced cancer starting slow release or transdermal opioids for pain, with a life expectancy of at least 1 month and no severe renal impairment.
04
Endpoints
Primary
Bowel Function Index score <30
Secondary
EuroQol-5 Dimension
Rome IV criteria for opioid-induced constipation
Cancer pain score
Patient satisfaction with laxative
Side effects of laxatives
Cost-effectiveness of macrogol/electrolytes compared to magnesium hydroxide
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