Clinical trial NCT02028923: Efficacy of Topical Morphine in the Treatment of Severe Local Pain of Chronic Wounds
Official title: Phase III Study Evaluating the Efficacy of Topical Morphine in the Treatment of Severe Local Pain of Chronic Wounds
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Local Pain
Chronic Wounds
Keywords: topical morphine
Lead sponsor: Institut Curie
Sponsor class: OTHER
Collaborators: name: Assistance Publique - Hôpitaux de Paris
name: Hôpital Louis Mourier
First posted: 2014-01-07
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.
* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
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
timeFrame: 11 days
Secondary outcomes:
measure: 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
timeFrame: 11 days
measure: Evaluate the percentage of local pain relief for 24 hours on a rating scale from 0 to 100%
timeFrame: 11 days
measure: 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)
timeFrame: 11 days
measure: Assess patient satisfaction with treatment of local pain (score 0-4)
timeFrame: 11 days
measure: Evaluate the impact score of local pain on sleep (self-report scale of 0 to 100%)
timeFrame: 11 days
measure: Determine the time (in hours) before using oral immediate-release morphine after application of local treatment
timeFrame: 11 days
measure: Determination of cumulative dose of oral immediate-release morphine (in milligrams) of the 11 days of treatment for relieving painful access of local origin
timeFrame: 11 days
measure: Evaluate systemic and local side effects of analgesic treatment (incidence, severity and location)
timeFrame: 11 days
measure: Evaluate the systemic absorption of topical morphine blood test after the first application
timeFrame: 11 days
Other outcomes:
Locations:
city: Colombes
country: France
facility: Hôpital Louis Mourier
state: Ile de France
city: Paris
country: France
facility: Institut Curie
state: Ile de France
city: Paris
country: France
facility: Hôpital Jean-Jaurès
state: Ile de France
city: Paris
country: France
facility: Groupe Hospitalier Bichat
state: Ile de France
city: Saint-Cloud
country: France
facility: Institut Curie - Hôpital René Huguenin
state: Ile de France
Study officials:
affiliation: Institut Curie - Hôpital René Huguenin
name: Valerie LAURENT, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Curie Paris
name: Audrey Hurgon, MD
role: STUDY_DIRECTOR
References: