Status:
COMPLETED
Topical Morphine for Stomatitis-related Pain Induced by Chemotherapy
Lead Sponsor:
Danish University of Pharmaceutical Sciences
Collaborating Sponsors:
Copenhagen University Hospital, Denmark
Conditions:
Pain
Mucositis
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
Stomatitis/oral mucositis is a common side effect to chemotherapy. Stomatitis is often associated with painful ulcers in the mouth. The study hypothesis is that morphine administrated as a mouthwash c...
Eligibility Criteria
Inclusion
- Children and adolescents at The Juliane Marie Center at Copenhagen University Hospital (Rigshospitalet, Denmark) or at The University Hospital in Lund (Sweden)
- Receiving chemotherapy in relation to a cancer disease
- Pain score of minimum 3 (VAS-scale) at rest for mouth pain in combination with stomatitis of minimum grade 1 (WHO-scale) or a pain score of minimum 5 (VAS-scale) at activity for mouth pain in combination with stomatitis of minimum grade 1 (WHO-scale)
- Negative pregnancy test, when relevant (judged by physician)
- Patients and/or parents understand and speak danish (Denmark) / swedish (Sweden)
- Signed informed consent
Exclusion
- Allergic to the investigational medical product
- Alcohol or drug abuse
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00357942
Start Date
September 1 2006
End Date
January 1 2014
Last Update
February 21 2014
Active Locations (1)
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1
The Juliane Marie Center, Copenhagen University Hospital (Rigshospitalet)
Copenhagen, Denmark, DK-2100