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Trial record 72 of 185 for:    ERYTHROMYCIN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02028923
Recruitment Status : Terminated (Recruiting patients too low)
First Posted : January 7, 2014
Last Update Posted : November 21, 2016
Sponsor:
Collaborators:
Assistance Publique - Hôpitaux de Paris
Hôpital Louis Mourier
Information provided by (Responsible Party):
Institut Curie

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.

Condition or disease Intervention/treatment Phase
Local Pain Chronic Wounds Drug: Morphine gel Other: Neutral gel Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase III Study Evaluating the Efficacy of Topical Morphine in the Treatment of Severe Local Pain of Chronic Wounds
Study Start Date : April 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Morphine gel
morphine 30 mg, quantity of gel per application: 15mg (15ml)
Drug: Morphine gel
Topical

Placebo Comparator: Neutral gel
water for injection, quantity of gel per application: 15mg (15ml)
Other: Neutral gel
Topical




Primary Outcome Measures :
  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 [ Time Frame: 11 days ]
    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


Secondary Outcome Measures :
  1. 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 [ Time Frame: 11 days ]
    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.

  2. Evaluate the percentage of local pain relief for 24 hours on a rating scale from 0 to 100% [ Time Frame: 11 days ]
  3. 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) [ Time Frame: 11 days ]
  4. Assess patient satisfaction with treatment of local pain (score 0-4) [ Time Frame: 11 days ]
  5. Evaluate the impact score of local pain on sleep (self-report scale of 0 to 100%) [ Time Frame: 11 days ]
    0% no impact of pain on sleep 100% maximum impact of pain on sleep, inability to sleep

  6. Determine the time (in hours) before using oral immediate-release morphine after application of local treatment [ Time Frame: 11 days ]
  7. Determination of cumulative dose of oral immediate-release morphine (in milligrams) of the 11 days of treatment for relieving painful access of local origin [ Time Frame: 11 days ]
  8. Evaluate systemic and local side effects of analgesic treatment (incidence, severity and location) [ Time Frame: 11 days ]
  9. Evaluate the systemic absorption of topical morphine blood test after the first application [ Time Frame: 11 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02028923


Locations
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France
Hôpital Louis Mourier
Colombes, Ile de France, France, 92700
Institut Curie
Paris, Ile de France, France, 75005
Hôpital Jean-Jaurès
Paris, Ile de France, France, 75019
Groupe Hospitalier Bichat
Paris, Ile de France, France, 75877
Institut Curie - Hôpital René Huguenin
Saint-Cloud, Ile de France, France, 92210
Sponsors and Collaborators
Institut Curie
Assistance Publique - Hôpitaux de Paris
Hôpital Louis Mourier
Investigators
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Principal Investigator: Valerie LAURENT, MD Institut Curie - Hôpital René Huguenin
Study Director: Audrey Hurgon, MD Institut Curie Paris

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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT02028923    
Other Study ID Numbers: IC 2013-01
First Posted: January 7, 2014    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: July 2016
Keywords provided by Institut Curie:
topical morphine
Additional relevant MeSH terms:
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Wounds and Injuries
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents