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

NCT02028923 | Terminated Phase 3

• 1 other identifier: IC 2013-01
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• 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

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

  11 days

• Evaluate the percentage of local pain relief for 24 hours on a rating scale from 0 to 100%

  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)

  11 days

• Assess patient satisfaction with treatment of local pain (score 0-4)

  11 days

• Evaluate the impact score of local pain on sleep (self-report scale of 0 to 100%)

  11 days

Study Arms (2)

Morphine gel

EXPERIMENTAL

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

Drug: Morphine gel

Neutral gel

PLACEBO COMPARATOR

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

Other: Neutral gel

Interventions

Morphine gel DRUG

Topical

Morphine gel

Neutral gel OTHER

Topical

Neutral gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Curie: lead
• Assistance Publique - Hôpitaux de Paris: collaborator
• Hôpital Louis Mourier: collaborator

Study Sites (5)

Hôpital Louis Mourier

Colombes, Île-de-France Region, 92700, France

Location

Institut Curie

Paris, Île-de-France Region, 75005, France

Location

Hôpital Jean-Jaurès

Paris, Île-de-France Region, 75019, France

Location

Groupe Hospitalier Bichat

Paris, Île-de-France Region, 75877, France

Location

Institut Curie - Hôpital René Huguenin

Saint-Cloud, Île-de-France Region, 92210, France

Location

Study Officials

• Valerie LAURENT, MD

  Institut Curie - Hôpital René Huguenin

  PRINCIPAL INVESTIGATOR

• Audrey Hurgon, MD

  Institut Curie Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 7, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: November 21, 2016

Record last verified: 2016-07

Locations

FR (5)