CancerPhase 3MorphinOgelNCT02173756
Evaluation of Oral Morphine Gel in Oral Mucositis Induced by Chemotherapy in Children and Young Adults
A Phase 3 study testing morphine gel in people with Cancer, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 5 to 25 years
- Conditions the study is for
- Cancer
- What is being tested?
- morphine gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Sep 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Patients in emergency ward -Patients having difficulties in understanding the study -
- Patients who have already been treated with oral morphine gel
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'oncohématologie pédiatrique, Hôpital de Hautepierre
Strasbourg, Alsace, 67098
About this study
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.
Read the detailed 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
- Conditions
- Cancer
- Being tested
- morphine gel, placebo gel
- Keywords
- chemotherapy, mucositis, systemic opioids, morphine
- Medical subject headings
- Neoplasms, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
morphine gelDrug
Also called Morphine hydrochloride,
1 mg / ml ofmorphine hydrochloride, presented in a 5 mL sterile syringe (single dose), raspberry aroma, 30% glucose
placebo gelDrug
Also called sterile 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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Daily assessment through out the mucositis
Secondary outcomes (4)
Evaluation of the local tolerance and other topical treatment taken throughout the mucositis
Evaluation of the local tolerance ( taste, burns) with a questionnaire
Measured: daily, 8-21 days throughout the mucositis
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
Measured: daily, 8-21 days throughout the mucositis
Evaluation of the local tolerance and other topical treatment taken throughout the mucositis
Daily grading of mucositis by the doctor
Measured: daily, 8-21 days throughout the mucositis
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)
Measured: daily, 8-21 days throughout the mucositis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2017
- Study completionSep 2017
Why it stopped: Numerous premature study discontinuations due to adverse events
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02173756
- Sponsor's protocol ID
- 5092
- Other IDs
- 2013-001686-16
- Acronym
- MorphinOgel
- Status last verified
- Jun 2014
- First submitted
- 14 Jun 2014
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oral Morphine Gel in Oral Mucositis Induced by Chemotherapy in Children and Young Adults
- ClinicalTrials.gov ID
- NCT02173756
- Acronym / sponsor ID
- MorphinOgel / 5092
- Conditions
- Cancer
- Keywords
- chemotherapy, mucositis, systemic opioids, morphine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Numerous premature study discontinuations due to adverse events
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 25 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral morphine gel | Experimental | Drug: morphine gel1 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). |
| placebo gel | Placebo comparator | Drug: placebo gel1 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). |
Who may qualify
- Ages
- 5 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Patients in emergency ward -Patients having difficulties in understanding the study -
- Patients who have already been treated with oral morphine gel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| morphine gelAlso: Morphine hydrochloride,1 mg / ml ofmorphine hydrochloride, presented in a 5 mL sterile syringe (single dose), raspberry aroma, 30% glucose | Drug | oral morphine gel |
| placebo gelAlso: sterile Placebo gelSterile 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 | Drug | placebo gel |
Primary outcome
change in pain of mucositis before and after meal
Time frame: Daily assessment through out the mucositis
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.
4 secondary outcomes
Evaluation of the local tolerance and other topical treatment taken throughout the mucositis
Time frame: daily, 8-21 days throughout the mucositis
Evaluation of the local tolerance and other topical treatment taken throughout the mucositis
Time frame: daily, 8-21 days throughout the mucositis
Evaluation of the local tolerance and other topical treatment taken throughout the mucositis
Time frame: daily, 8-21 days throughout the mucositis
Evaluation of the local tolerance and other topical treatment taken throughout the mucositis
Time frame: daily, 8-21 days throughout the mucositis
Results and safety
The study was stopped early (reason given: Numerous premature study discontinuations due to adverse events). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing morphine gel in people with Cancer, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Numerous premature study discontinuations due to adverse events). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in pain of mucositis before and after meal (time frame: Daily assessment through out the mucositis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.