Topical Morphine for Stomatitis-related Pain Induced by Chemotherapy
NCT ID: NCT00357942
Last Updated: 2014-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
72 participants
INTERVENTIONAL
2006-09-30
2014-01-31
Brief Summary
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The purpose of this study is to test the analgesic effect of a morphine mouthwash versus morphine injections or placebo (no active drug) in children/adolescents with stomatitis related to chemotherapy. Besides the investigational drugs (morphine mouthwash and morphine injections) the children/adolescents receive a standardized analgesic treatment for stomatitis-related pain.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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C group I
Morphine mouthwash and placebo i.v.(24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)
morphine mouthwash
morphine mouthwash 2 mg/ml, 50 microg/kg bodyweight every 3 hour for 24 hours and placebo solution for injection
Placebo
Placebo solution for injection every 3 hour for 24 hours
C group II
Placebo mouthwash and morphine i.v.(24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)
morphine solution for injection
morphine solution for injection 2 mg/ml, 50 microg/kg bodyweight, every 3 hour for 24 hours and placebo mouthwash
Placebo
Placebo mouthwash
C group III
Placebo mouthwash and placebo i.v. (24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)
Placebo
Placebo mouthwash
Placebo
Placebo solution for injection every 3 hour for 24 hours
Interventions
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morphine solution for injection
morphine solution for injection 2 mg/ml, 50 microg/kg bodyweight, every 3 hour for 24 hours and placebo mouthwash
Placebo
Placebo mouthwash
morphine mouthwash
morphine mouthwash 2 mg/ml, 50 microg/kg bodyweight every 3 hour for 24 hours and placebo solution for injection
Placebo
Placebo solution for injection every 3 hour for 24 hours
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Alcohol or drug abuse
ALL
No
Sponsors
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Copenhagen University Hospital, Denmark
OTHER
Danish University of Pharmaceutical Sciences
OTHER
Responsible Party
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Bettina Nygaard Nielsen
M.Sc. Pharm, sponsor contact person
Principal Investigators
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Bettina N Nielsen, PhD student M.Sc.Pharm
Role: STUDY_CHAIR
Faculty of Pharmaceutical Sciences, University of Copenhagen
Locations
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The Juliane Marie Center, Copenhagen University Hospital (Rigshospitalet)
Copenhagen, , Denmark
Countries
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Other Identifiers
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2006-003260-53
Identifier Type: -
Identifier Source: secondary_id
2006-003260-53
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
102010
Identifier Type: -
Identifier Source: org_study_id
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