Efficacy of Topical Morphine in the Treatment of Severe Local Pain of Chronic Wounds (EMGEL)

Institut Curie

Status and phase

Terminated

Phase 3

Conditions

Chronic Wounds

Local Pain

Treatments

Other: Neutral gel

Drug: Morphine gel

Study type

Interventional

Funder types

Other

Identifiers

NCT02028923

IC 2013-01

Details and patient eligibility

About

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.

Enrollment

126 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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