Topical Morphine for Stomatitis-related Pain Induced by Chemotherapy

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00357942
• Other study ID #: 102010
• Secondary ID: 2006-003260-5320
• Status: Completed
• Phase: Phase 4
• First received: July 27, 2006
• Last updated: February 20, 2014
• Start date: September 2006
• Est. completion date: January 2014

Study information

• Verified date: February 2014
• Source: Danish University of Pharmaceutical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mucositis
• Pain
• Stomatitis

Intervention

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
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

Locations

Country	Name	City	State
Denmark	The Juliane Marie Center, Copenhagen University Hospital (Rigshospitalet)	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Danish University of Pharmaceutical Sciences	Copenhagen University Hospital, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of supplemental analgesics		24 hours	No
Secondary	Pain score at rest		24 hours	No
Secondary	Pain score at activity (performance of oral hygiene)		24 hours	No
Secondary	Time to first dose of supplemental analgesics		24 hours	No
Secondary	Frequency and severity of side effects		24 hours	Yes
Secondary	Oral intake of food		24 hours	No