Clinical trial · Interventional
Evaluation of Oral Morphine Gel in Oral Mucositis Induced by Chemotherapy in Children and Young Adults
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Numerous premature study discontinuations due to adverse events
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| morphine gel | Drug | — | UNRESOLVED |
| placebo gel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- oral morphine gel
- description
- 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).
- interventionNames
- Drug: morphine gel
- type
- PLACEBO_COMPARATOR
- label
- placebo gel
- description
- 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).
- interventionNames
- Drug: placebo gel
Primary outcomes (1)
- measure
- change in pain of mucositis before and after meal
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 25 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available