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Loop: Loperamide vs Tincture of Opium for Radiation-Induced Diarrhea
NCT00444093Phase 3
Key facts
- Status
- Terminated
- Start
- Mar 2007
- Primary completion
- Feb 2008
- Sponsor
- Philipps-Universität Marburg
- Modality
- Covalent Small Molecules, Classical Binding Small Molecules, Nucleic Acid-Directed Small Molecules
- Drugs
- opium tincture
- Conditions
- radiation enteritis
01
Overview
Phase 3, randomised, open-label trial of opium tincture in radiation enteritis (2 arms), sponsored by Philipps-Universität Marburg. Primary endpoint: Treatment Efficacy at 90 days. Started Mar 2007; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
Opii normata treatment
Tincture of opium drops
Loperamid Treatment
Loperamide tablets/capsules
03
Who it enrols
Adult patients undergoing percutaneous radiation therapy for pelvic malignancies (rectal, prostate, endometrial, cervix) with grade 1-2 diarrhea, excluding those with severe liver/kidney/heart dysfunction, brain injury, epilepsy, or history of addiction.
04
Endpoints
Primary
Treatment Efficacy
Secondary
Quality of life EORTC-QLQ C30
Diarrhea Assessment
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