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Topical Morphine for Stomatitis-related Pain Induced by Chemotherapy

Primary Purpose

Pain, Mucositis

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
morphine solution for injection
Placebo
morphine mouthwash
Placebo
Sponsored by
Danish University of Pharmaceutical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Morphine, Mouthwash, Mucositis, Pain, Cancer, Child, Adolescent

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Juliane Marie Center, Copenhagen University Hospital (Rigshospitalet)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

C group I

C group II

C group III

Arm Description

Morphine mouthwash and placebo i.v.(24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)

Placebo mouthwash and morphine i.v.(24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)

Placebo mouthwash and placebo i.v. (24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)

Outcomes

Primary Outcome Measures

Use of supplemental analgesics

Secondary Outcome Measures

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

Full Information

First Posted
July 27, 2006
Last Updated
February 20, 2014
Sponsor
Danish University of Pharmaceutical Sciences
Collaborators
Copenhagen University Hospital, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00357942
Brief Title
Topical Morphine for Stomatitis-related Pain Induced by Chemotherapy
Official Title
Local Administration of Morphine: An Evaluation of the Analgesic Effect at Stomatitis in Children
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish University of Pharmaceutical Sciences
Collaborators
Copenhagen University Hospital, Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Mucositis
Keywords
Morphine, Mouthwash, Mucositis, Pain, Cancer, Child, Adolescent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
C group I
Arm Type
Experimental
Arm Description
Morphine mouthwash and placebo i.v.(24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)
Arm Title
C group II
Arm Type
Active Comparator
Arm Description
Placebo mouthwash and morphine i.v.(24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)
Arm Title
C group III
Arm Type
Placebo Comparator
Arm Description
Placebo mouthwash and placebo i.v. (24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)
Intervention Type
Drug
Intervention Name(s)
morphine solution for injection
Intervention Description
morphine solution for injection 2 mg/ml, 50 microg/kg bodyweight, every 3 hour for 24 hours and placebo mouthwash
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo mouthwash
Intervention Type
Drug
Intervention Name(s)
morphine mouthwash
Intervention Description
morphine mouthwash 2 mg/ml, 50 microg/kg bodyweight every 3 hour for 24 hours and placebo solution for injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo solution for injection every 3 hour for 24 hours
Primary Outcome Measure Information:
Title
Use of supplemental analgesics
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Pain score at rest
Time Frame
24 hours
Title
Pain score at activity (performance of oral hygiene)
Time Frame
24 hours
Title
Time to first dose of supplemental analgesics
Time Frame
24 hours
Title
Frequency and severity of side effects
Time Frame
24 hours
Title
Oral intake of food
Time Frame
24 hours

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bettina N Nielsen, PhD student M.Sc.Pharm
Organizational Affiliation
Faculty of Pharmaceutical Sciences, University of Copenhagen
Official's Role
Study Chair
Facility Information:
Facility Name
The Juliane Marie Center, Copenhagen University Hospital (Rigshospitalet)
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark

12. IPD Sharing Statement

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Topical Morphine for Stomatitis-related Pain Induced by Chemotherapy

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