Local PainPhase 3EMGELNCT02028923
Efficacy of Topical Morphine in the Treatment of Severe Local Pain of Chronic Wounds
A Phase 3 study testing Morphine gel and Neutral gel in people with Local Pain and Chronic Wounds, run by Institut Curie at 5 sites in France.
Trial summary
This phase III study aims to show that topical morphine low doses treats localized pain in chronic wounds, intense and rebellious to systemic analgesics included or not opioids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Local Pain, Chronic Wounds
- What is being tested?
- Morphine gel and Neutral gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 5 sitesFrance
- Study dates
- Apr 2014to Jul 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged over 18 years
- Painful chronic wounds (bedsores, wound tumor, arterial ulcers, venous or mixed diabetic ulcer if systolic pressure index >0.8, necrotic angiodermatitis not graftable), a bottom surface 300 cm² and does not require more than 15 ml of gel by application. When patient has multiple painful chronic wounds, the wound having only the highest pain intensity is considered for evaluation.
- Ineffective systemic analgesic with or without opioid analgesic established and maintained at the same dose for 3 days before inclusion. If treatment includes morphine, the daily dose should not exceed 60 mg of morphine equivalent and this treatment must be a treatment exclusive background.
- Patient requiring an analgesic equilibration for intense and rebellious local pain, with a daily average score greater than or equal to 5, on a graduated numerical scale of 0 to 10. The score is defined at the inclusion and corresponds to the pain intensity felt locally by the patient under treatment systemic analgesic with or without co-analgesics.
- If analgesics to treat systemic pain is ongoing, it must have been introduced for more than 3 days (according to criteria 3)
- If antidepressant treatment is in progress, it must have been established for over a month for a tricyclic and for more than 15 days for other classes of antidepressants.
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- If an anti-epileptic treatment analgesic is in progress, it must have been established for over 15 days.
- Signing of the informed consent form.
- Patient able to respond the self-assessment questionnaires (sufficient understanding assessments, proficiency in French).
- Patient affiliated to an health insurance plan
Who cannot join
- Allergy to morphine or carboxymethylcellulose or history of intolerance to morphine
- Analgesic at baseline including systemic morphine to greater than 60 mg equivalent dose of morphine treatment
- Fistulated wound
- Heavily exuding wound
- Wound bleeding (spontaneous bleeding)
- Ongoing radiotherapy on chronic wound
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- Creatinine > 110 µmol/L, Total bilirubin > 20 µmol/L
- Not communicating patient
- Unable to comply with requirement of the protocol (11 days)
- Patient pregnant or of childbearing age without contraceptive therapy or lactating
- Person deprived of liberty or under guardianship
- Only for pharmacokinetic analysis: analgesics at baseline including morphine or hydromorphone or oxycodone or codeine. Fentanyl is allowed
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Hôpital Louis Mourier
Colombes, Île-de-France Region, 92700
Institut Curie
Paris, Île-de-France Region, 75005
Hôpital Jean-Jaurès
Paris, Île-de-France Region, 75019
Groupe Hospitalier Bichat
Paris, Île-de-France Region, 75877
Institut Curie - Hôpital René Huguenin
Saint-Cloud, Île-de-France Region, 92210
About this study
Official title: Phase III Study Evaluating the Efficacy of Topical Morphine in the Treatment of Severe Local Pain of Chronic Wounds
This phase III study aims to show that topical morphine low doses treats localized pain in chronic wounds, intense and rebellious to systemic analgesics included or not opioids.
- Conditions
- Local Pain, Chronic Wounds
- Being tested
- Morphine gel, Neutral gel
- Keywords
- topical morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine gelDrug
Topical
Neutral gelOther
Topical
| Study group | Role | What they receive |
|---|---|---|
| Morphine gel | Experimental | morphine 30 mg, quantity of gel per application: 15mg (15ml) Receives: Drug: Morphine gel |
| Neutral gel | Placebo comparator | water for injection, quantity of gel per application: 15mg (15ml) Receives: Other: Neutral gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients whose maximum daily consumption in immediate-release oral morphine is less than or equal to 30 mg for the last 72 hours of the study
Proportion of patients whose maximum daily consumption in immediate-release oral morphine is less than or equal to 30 mg (either up to 3 tablets 10 mg per day) for the last 72 hours of the study (day 8 to day 11) and for which the basic treatment is unchanged throughout the duration of the study
Measured: 11 days
Secondary outcomes (9)
Reduction in average daily pain intensity score on a numerical rating scale self assessment, measured on an 11-point between day 1 and day 11
Reduction in average daily pain intensity score on a numerical rating scale (where 0=no pain and 10=worst possible pain) self assessment, measured on an 11-point between day 1 and day 11. Therefore patients evaluate each morning local pain of the previous 24 hours.
Measured: 11 days
Evaluate the percentage of local pain relief for 24 hours on a rating scale from 0 to 100%
Measured: 11 days
Assess and characterize the evolution of local pain on a global impression scale change : Pain related Patient Global Impression of Change (PGIC) and Clinical Global Impression of Change (CGIC)
Measured: 11 days
Assess patient satisfaction with treatment of local pain (score 0-4)
Measured: 11 days
Evaluate the impact score of local pain on sleep (self-report scale of 0 to 100%)
0% no impact of pain on sleep 100% maximum impact of pain on sleep, inability to sleep
Measured: 11 days
Determine the time (in hours) before using oral immediate-release morphine after application of local treatment
Measured: 11 days
Determination of cumulative dose of oral immediate-release morphine (in milligrams) of the 11 days of treatment for relieving painful access of local origin
Measured: 11 days
Evaluate systemic and local side effects of analgesic treatment (incidence, severity and location)
Measured: 11 days
Evaluate the systemic absorption of topical morphine blood test after the first application
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2016
- Study completionJul 2016
Why it stopped: Recruiting patients too low
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local PainStudies of the same condition, open and under way.
- 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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris, Hôpital Louis Mourier
- Responsible party
- Sponsor
- Investigators
- Valerie LAURENT, MD, Principal investigator, Institut Curie - Hôpital René HugueninAudrey Hurgon, MD, Study director, Institut Curie Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028923
- Sponsor's protocol ID
- IC 2013-01
- Acronym
- EMGEL
- Status last verified
- Jul 2016
- First submitted
- 6 Jan 2014
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study Evaluating the Efficacy of Topical Morphine in the Treatment of Severe Local Pain of Chronic Wounds
- ClinicalTrials.gov ID
- NCT02028923
- Acronym / sponsor ID
- EMGEL / IC 2013-01
- Conditions
- Local Pain, Chronic Wounds
- Keywords
- topical morphine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruiting patients too low
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris, Hôpital Louis Mourier
- Study start
- Apr 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 7 Jan 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.
This phase III study aims to show that topical morphine low doses treats localized pain in chronic wounds, intense and rebellious to systemic analgesics included or not 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 |
|---|---|---|
| Morphine gel | Experimental | Drug: Morphine gelmorphine 30 mg, quantity of gel per application: 15mg (15ml) |
| Neutral gel | Placebo comparator | Other: Neutral gelwater for injection, quantity of gel per application: 15mg (15ml) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female, aged over 18 years
- Painful chronic wounds (bedsores, wound tumor, arterial ulcers, venous or mixed diabetic ulcer if systolic pressure index >0.8, necrotic angiodermatitis not graftable), a bottom surface 300 cm² and does not require more than 15 ml of gel by application. When patient has multiple painful chronic wounds, the wound having only the highest pain intensity is considered for evaluation.
- Ineffective systemic analgesic with or without opioid analgesic established and maintained at the same dose for 3 days before inclusion. If treatment includes morphine, the daily dose should not exceed 60 mg of morphine equivalent and this treatment must be a treatment exclusive background.
- Patient requiring an analgesic equilibration for intense and rebellious local pain, with a daily average score greater than or equal to 5, on a graduated numerical scale of 0 to 10. The score is defined at the inclusion and corresponds to the pain intensity felt locally by the patient under treatment systemic analgesic with or without co-analgesics.
- If analgesics to treat systemic pain is ongoing, it must have been introduced for more than 3 days (according to criteria 3)
Key exclusion criteria (12 listed)
- Allergy to morphine or carboxymethylcellulose or history of intolerance to morphine
- Analgesic at baseline including systemic morphine to greater than 60 mg equivalent dose of morphine treatment
- Fistulated wound
- Heavily exuding wound
- Wound bleeding (spontaneous bleeding)
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 gelTopical | Drug | Morphine gel |
| Neutral gelTopical | Other | Neutral gel |
Primary outcome
Proportion of patients whose maximum daily consumption in immediate-release oral morphine is less than or equal to 30 mg for the last 72 hours of the study
Time frame: 11 days
Proportion of patients whose maximum daily consumption in immediate-release oral morphine is less than or equal to 30 mg (either up to 3 tablets 10 mg per day) for the last 72 hours of the study (day 8 to day 11) and for which the basic treatment is unchanged throughout the duration of the study
9 secondary outcomes
Reduction in average daily pain intensity score on a numerical rating scale self assessment, measured on an 11-point between day 1 and day 11
Time frame: 11 days
Evaluate the percentage of local pain relief for 24 hours on a rating scale from 0 to 100%
Time frame: 11 days
Assess and characterize the evolution of local pain on a global impression scale change : Pain related Patient Global Impression of Change (PGIC) and Clinical Global Impression of Change (CGIC)
Time frame: 11 days
Assess patient satisfaction with treatment of local pain (score 0-4)
Time frame: 11 days
Evaluate the impact score of local pain on sleep (self-report scale of 0 to 100%)
Time frame: 11 days
Determine the time (in hours) before using oral immediate-release morphine after application of local treatment
Time frame: 11 days
Determination of cumulative dose of oral immediate-release morphine (in milligrams) of the 11 days of treatment for relieving painful access of local origin
Time frame: 11 days
Evaluate systemic and local side effects of analgesic treatment (incidence, severity and location)
Time frame: 11 days
Evaluate the systemic absorption of topical morphine blood test after the first application
Time frame: 11 days
Results and safety
The study was stopped early (reason given: Recruiting patients too low). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2016.
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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.
Valerie LAURENT, MD principal investigator
Institut Curie - Hôpital René Huguenin
Audrey Hurgon, MD study director
Institut Curie Paris
5 sites 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 and Neutral gel in people with Local Pain and Chronic Wounds, run by Institut Curie at 5 sites 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 10 inclusion and 12 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 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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: Recruiting patients too low). 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?
Proportion of patients whose maximum daily consumption in immediate-release oral morphine is less than or equal to 30 mg for the last 72 hours of the study (time frame: 11 days). 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 21 Nov 2016.