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

Chronic Wounds Clinical Trial

— EMGEL  

Official title:

Phase III Study Evaluating the Efficacy of Topical Morphine in the Treatment of Severe Local Pain of Chronic Wounds

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02028923
• Other study ID #: IC 2013-01
• Status: Terminated
• Phase: Phase 3
• First received: January 6, 2014
• Last updated: November 18, 2016
• Start date: April 2014
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 126
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Wounds
• Local Pain
• Wounds and Injuries

Intervention

Drug:
• Morphine gel
Topical

Other:
• Neutral gel
Topical

Locations

Country	Name	City	State
France	Hôpital Louis Mourier	Colombes	Ile de France
France	Groupe Hospitalier Bichat	Paris	Ile de France
France	Hôpital Jean-Jaurès	Paris	Ile de France
France	Institut Curie	Paris	Ile de France
France	Institut Curie - Hôpital René Huguenin	Saint-Cloud	Ile de France

Sponsors (3)

Lead Sponsor	Collaborator
Institut Curie	Assistance Publique - Hôpitaux de Paris, Hôpital Louis Mourier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	11 days	No
Secondary	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.	11 days	No
Secondary	Evaluate the percentage of local pain relief for 24 hours on a rating scale from 0 to 100%		11 days	No
Secondary	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)		11 days	No
Secondary	Assess patient satisfaction with treatment of local pain (score 0-4)		11 days	No
Secondary	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	11 days	No
Secondary	Determine the time (in hours) before using oral immediate-release morphine after application of local treatment		11 days	No
Secondary	Determination of cumulative dose of oral immediate-release morphine (in milligrams) of the 11 days of treatment for relieving painful access of local origin		11 days	No
Secondary	Evaluate systemic and local side effects of analgesic treatment (incidence, severity and location)		11 days	No
Secondary	Evaluate the systemic absorption of topical morphine blood test after the first application		11 days	No