Evaluation of Oral Morphine Gel in Oral Mucositis Induced by Chemotherapy in Children and Young Adults

Cancer Clinical Trial

— MorphinOgel  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02173756
• Other study ID #: 5092
• Status: Not yet recruiting
• Phase: Phase 3
• First received: June 14, 2014
• Last updated: June 20, 2014
• Start date: June 2014
• Est. completion date: June 2016

Study information

• Verified date: June 2014
• Source: University Hospital, Strasbourg, France
• Contact: Patrick Lutz, MD
• Phone: 0388128091
• Email: patrick.lutz[@]chru-strasbourg.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Chemotherapy kills tumor cells but can also damage healthy cells and cause significant digestive disorders such as ulcers of the mouth, called mucositis. Mucositis are transient but their intensity may require special measures. Mucositis are painful and morphine gel or intravenous morphine is used to relieve pain.

However, the pain of oral mucositis induced by chemotherapy is not completely relieved by morphine administered intravenously.

As part of the study, the investigators want to evaluate an oral gel containing a small amount of morphine so that it acts directly on the mucositis. The investigators believe that the direct action of morphine on mucositis may be more effective on pain.

Description:

The objective of the study is to compare the analgesic efficacy of topical morphine gel versus placebo gel in the pediatric oncohaematology oral mucositis induced by chemotherapy in children treated with systemic opioids.

To confirm these results, we propose to conduct a randomized double-blinded study designed to compare the analgesic efficacy of morphine oral topical gel versus placebo gel in children over 5 years with mucositis induced by chemotherapy and treated with systemic opioids. This analgesic effect should reduce persistent pain to maintain oral feeding and thus delay the implementation of parenteral nutrition, and hence reduce the dose of systemic morphine and also reduce the adverse effects of opioids

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 25 Years

Eligibility

Inclusion Criteria:

• Children older than 5 years or adults over 18 and up to 25 years with a chemotherapy

• greater than or equal to grade 2 mucositis that has lasted for 24 hours and treated with systemic opioid

Exclusion Criteria:

• Patients in emergency ward -Patients having difficulties in understanding the study -

• Patients who have already been treated with oral morphine gel

Study Design

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

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• morphine gel
1 mg / ml ofmorphine hydrochloride, presented in a 5 mL sterile syringe (single dose), raspberry aroma, 30% glucose
• placebo gel
Sterile placebo gel with raspberry aroma, 30% glucose presented in 5 mL syringe (single dose) of the same appearance and the same packaging as morphine gel to maintain the blind

Locations

Country	Name	City	State
France	Service d'oncohématologie pédiatrique, Hôpital de Hautepierre	Strasbourg	Alsace

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in pain of mucositis before and after meal	Pain is assessed before gel application and 30 minutes after application (i e 8 times per day and for the duration of the mucositis between 8 to 21 days). The gel is administered 4 times daily 30 minutes before each meal. Response to treatment is defined as a greater than or equal to 30% decrease in pain level between before and after application of the gel.	Daily assessment through out the mucositis	Yes
Secondary	Evaluation of the local tolerance and other topical treatment taken throughout the mucositis	Evaluation of the local tolerance ( taste, burns) with a questionnaire	daily, 8-21 days throughout the mucositis	Yes
Secondary	Evaluation of the local tolerance and other topical treatment taken throughout the mucositis	Assessment of the quantity of morphine in mg/ day (reported in mg morphine), the nature and amount of all systemic analgesics	daily, 8-21 days throughout the mucositis	Yes
Secondary	Evaluation of the local tolerance and other topical treatment taken throughout the mucositis	Daily grading of mucositis by the doctor	daily, 8-21 days throughout the mucositis	Yes
Secondary	Evaluation of the local tolerance and other topical treatment taken throughout the mucositis	Daily evaluation of other topical treatments administered (mouthwashes: time frames when administered, doses, nature)	daily, 8-21 days throughout the mucositis	Yes