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

NCT02173756 | Terminated Phase 3

• 2 other identifiers: 50922013-001686-16
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer

Keywords

chemotherapy; mucositis; systemic opioids; morphine

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Evaluation of the local tolerance and other topical treatment taken throughout the mucositis

  daily, 8-21 days throughout the mucositis

• Evaluation of the local tolerance and other topical treatment taken throughout the mucositis

  daily, 8-21 days throughout the mucositis

• Evaluation of the local tolerance and other topical treatment taken throughout the mucositis

  daily, 8-21 days throughout the mucositis

• Evaluation of the local tolerance and other topical treatment taken throughout the mucositis

  daily, 8-21 days throughout the mucositis

Study Arms (2)

oral morphine gel

EXPERIMENTAL

1 mg / ml of Morphine hydrochloride, presented in a 5 mL sterile syringe (single dose). Gel will be applied 8 times per day and for the duration of the mucositis (between 8 to 21 days).

Drug: morphine gel

placebo gel

PLACEBO COMPARATOR

1 mg / ml of Placebo gel that is presented in a 5 mL sterile syringe (single dose). Gel will be applied 8 times per day and for the duration of the mucositis (between 8 to 21 days).

Drug: placebo gel

Interventions

placebo gel DRUG

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

Also known as: sterile Placebo gel

placebo gel

morphine gel DRUG

1 mg / ml ofmorphine hydrochloride, presented in a 5 mL sterile syringe (single dose), raspberry aroma, 30% glucose

Also known as: Morphine hydrochloride,

oral morphine gel

Eligibility Criteria

• Age: 5 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Patients in emergency ward -Patients having difficulties in understanding the study -
• Patients who have already been treated with oral morphine gel

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service d'oncohématologie pédiatrique, Hôpital de Hautepierre

Strasbourg, Alsace, 67098, France

Location

MeSH Terms

Conditions

Neoplasms; Mucositis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2014
• First Posted: June 25, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: March 16, 2026

Record last verified: 2014-06

Locations

FR (1)