Topical administration of Morphine: Evaluation of the analgesic effect in children with stomatitis.

Phase 1

• Conditions: Stomatitis as a side-effect to chemotherapy.; MedDRA version: 8.1Level: LLTClassification code 10042128Term: Stomatitis

• Registration Number: EUCTR2006-003260-53-SE
• Lead Sponsor: The Faculty of Pharmaceutical Sciences, University of Copenhagen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-09-20
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

•Children and adolescents hospitalized at Lund Universtitetssjukhus, Sweden
•Receiving chemotherapy treatment for a cancer disease.
•Pain score = 3 (VAS-scale) at rest for oral pain combined with stomatitis = grad 1 (WHO-scale) or pain score = 5 (VAS-scale) at activity for oral pain combined with stomatitis = grad 1 (WHO-scale).
•Patient and/or parents must understand and speak swedish.
•Negative pregnancy test for girls whom it is considered of relvance*.
•Written and informed consent.

*of relevance is when the doctor who is performing the inclusion of the patient into the clinical trial assess that there is a need for a pregnancy test to exclude pregnancy for fertile girls who receive chemotherapy and are hospitalized.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Allergic to morphine or other of the substances in the investigational medical product.
•Alcohol- or medicine abuse.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): •Supplemental use of analgetics (morphine, Patient Controlled Analgesia) ;Main Objective: To investigate the analgesic effect of morphine versus placebo applied topically at stomatitis-related pain caused by chemotherapy in children.<br><br> ;Secondary Objective: To investigate the peripheral analgesic effect of morphine applied topically versus intravenous morphine and placebo at stomatitis-related pain caused by chemotherapy in children.<br>