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Topical Morphine for Stomatitis-related Pain Induced by Chemotherapy

NCT00357942 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2014-02-21

No results posted yet for this study

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 can relieve stomatitis-related pain by a local analgesic effect.

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.

Conditions

Interventions

DRUG

morphine solution for injection

morphine solution for injection 2 mg/ml, 50 microg/kg bodyweight, every 3 hour for 24 hours and placebo mouthwash

DRUG

Placebo

Placebo mouthwash

DRUG

morphine mouthwash

morphine mouthwash 2 mg/ml, 50 microg/kg bodyweight every 3 hour for 24 hours and placebo solution for injection

DRUG

Placebo

Placebo solution for injection every 3 hour for 24 hours

Sponsors & Collaborators

  • Copenhagen University Hospital, Denmark

    collaborator OTHER

  • Danish University of Pharmaceutical Sciences

    lead OTHER

Principal Investigators

  • Bettina N Nielsen, PhD student M.Sc.Pharm · Faculty of Pharmaceutical Sciences, University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2013-12-31
Completion
2014-01-31

Countries

  • Denmark

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00357942 on ClinicalTrials.gov