Topical Morphine for Stomatitis-related Pain Induced by Chemotherapy

Phase 4

Completed

• Conditions: Pain; Mucositis
• Interventions: Drug: morphine mouthwash; Drug: morphine solution for injection; Drug: Placebo

• Registration Number: NCT00357942
• Lead Sponsor: Danish University of Pharmaceutical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-07-27
• Study First Submitted QC: 2006-07-27
• Study First Posted: 2006-07-28
• Study Start: 2006-09
• Primary Completion: 2013-12
• Study Completion: 2014-01
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-20
• Last Update Posted: 2014-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C group I	morphine mouthwash	Morphine mouthwash and placebo i.v.(24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)
C group I	Placebo	Morphine mouthwash and placebo i.v.(24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)
C group II	morphine solution for injection	Placebo mouthwash and morphine i.v.(24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)
C group II	Placebo	Placebo mouthwash and morphine i.v.(24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)
C group III	Placebo	Placebo mouthwash and placebo i.v. (24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)

Primary Outcome Measures

Name	Time	Method
Use of supplemental analgesics	24 hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Juliane Marie Center, Copenhagen University Hospital (Rigshospitalet); 🇩🇰 Copenhagen, Denmark