Topical Morphine for Stomatitis-related Pain Induced by Chemotherapy

February 20, 2014 updated by: Bettina Nygaard Nielsen, Danish University of Pharmaceutical Sciences

Local Administration of Morphine: An Evaluation of the Analgesic Effect at Stomatitis in Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, DK-2100
        • The Juliane Marie Center, Copenhagen University Hospital (Rigshospitalet)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • Allergic to the investigational medical product
  • Alcohol or drug abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: C group I
Morphine mouthwash and placebo i.v.(24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)
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
Active Comparator: C group II
Placebo mouthwash and morphine i.v.(24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)
Drug: Placebo
Placebo mouthwash
Drug: Placebo
Placebo solution for injection every 3 hour for 24 hours
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
Placebo Comparator: C group III
Placebo mouthwash and placebo i.v. (24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)
Drug: Placebo
Placebo mouthwash
Drug: Placebo
Placebo solution for injection every 3 hour for 24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Use of supplemental analgesics
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain score at rest
Time Frame: 24 hours
24 hours
Pain score at activity (performance of oral hygiene)
Time Frame: 24 hours
24 hours
Time to first dose of supplemental analgesics
Time Frame: 24 hours
24 hours
Frequency and severity of side effects
Time Frame: 24 hours
24 hours
Oral intake of food
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish University of Pharmaceutical Sciences

Collaborators

Copenhagen University Hospital, Denmark

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

July 27, 2006

First Submitted That Met QC Criteria

July 27, 2006

First Posted (Estimate)

July 28, 2006

Study Record Updates

Last Update Posted (Estimate)

February 21, 2014

Last Update Submitted That Met QC Criteria

February 20, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102010
  • 2006-003260-53 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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