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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

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

NCT ID

NCT00357942

First Posted

July 27, 2006

Last Updated

February 20, 2014

Sponsor

Danish University of Pharmaceutical Sciences

Collaborators

Copenhagen University Hospital, Denmark

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

Eligibility Criteria

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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