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

NCT ID: NCT02028923

Last Updated: 2016-11-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-07-31

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.

Conditions

Local Pain; Chronic Wounds

Keywords

topical morphine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Morphine gel

morphine 30 mg, quantity of gel per application: 15mg (15ml)

Group Type: EXPERIMENTAL

Morphine gel

Intervention Type: DRUG

Topical

Neutral gel

water for injection, quantity of gel per application: 15mg (15ml)

Group Type: PLACEBO_COMPARATOR

Neutral gel

Intervention Type: OTHER

Topical

Interventions

Morphine gel

Topical

Intervention Type: DRUG

Neutral gel

Topical

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: collaborator

Hôpital Louis Mourier

OTHER

Sponsor Role: collaborator

Institut Curie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valerie LAURENT, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Curie - Hôpital René Huguenin

Audrey Hurgon, MD

Role: STUDY_DIRECTOR

Institut Curie Paris

Locations

Hôpital Louis Mourier

Colombes, Île-de-France Region, France

Institut Curie

Paris, Île-de-France Region, France

Hôpital Jean-Jaurès

Paris, Île-de-France Region, France

Groupe Hospitalier Bichat

Paris, Île-de-France Region, France

Institut Curie - Hôpital René Huguenin

Saint-Cloud, Île-de-France Region, France

Countries

France

Other Identifiers

IC 2013-01

Identifier Type: -

Identifier Source: org_study_id