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Sponsors and Collaborators: |
Soroka University Medical Center Israel Cancer Association |
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Information provided by: | Soroka University Medical Center |
ClinicalTrials.gov Identifier: | NCT00306020 |
Cutaneous cancer-related pain is difficult to treat. These patients are often prescribed high systemic dosages of opioids. Yet, many patients continue to report pain while experiencing dose-limiting side effects. An alternative approach to systemic administration is to apply topical medications. The advantage of topical application is the potential of achieving good analgesia using low dosages with few, if any, systemic side effects. Current clinical data indicates, that topically applied morphine has an analgesic effect in patients with severe pain and that it may even improve wound healing. The clinical reports so far have been either case studies or double blind randomly controlled trials with a very small sample size of patients. There is still a great deal of information which is lacking about this modality of treatment regarding on the one hand, the mechanism of action and on the other, clinical issues. For example, is the mechanism of the effect actually peripheral? What is the adequate dose of analgesic medication for different types of skin conditions? Wound healing has not been quantified. We will apply morphine topically to skin wounds of cancer and evaluate the effect of the treatment on pain, side effects, quantify wound healing, quantify morphine and its metabolites in blood and urine. Should well controlled studies, demonstrate all or any of the peripheral effects of topical morphine, clinical application of this treatment modality would be possible. This could contribute towards better treatment of these patients, who have pain which is difficult to treat and can, at times, be intractable.
Condition | Intervention |
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Ulcer Wounds and Injuries |
Drug: topical morphine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Estimated Enrollment: | 60 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | December 2008 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pesach Shvartzman, MD | 972-8-6477429 | spesah@bgu.ac.il |
Israel | |
Ben-Gurion University of the Negev, Sial Research Center for Family Medicine and Primary Care | Recruiting |
Beer-Sheva, Israel, POB 653, 84105 | |
Contact: Pesach Shvartzma, MD 972-8-6477429 spesah@bgu.ac.il | |
Sub-Investigator: Silviu Brill, MD |
Principal Investigator: | Pesach Shvartzman, Professor | Ben-Gurion University of the Negev, Sial Research Center for Family Medicine and Primary Care |
Study ID Numbers: | SOR394105CTIL |
Study First Received: | March 21, 2006 |
Last Updated: | March 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00306020 History of Changes |
Health Authority: | Israel: Ministry of Health |
Skin ulcers Topical morphine Chronic pain Cancer |
Morphine Ulcer Wounds and Injuries Central Nervous System Depressants Disorders of Environmental Origin Narcotics |
Pain Peripheral Nervous System Agents Analgesics Skin Ulcer Analgesics, Opioid |
Morphine Physiological Effects of Drugs Wounds and Injuries Disorders of Environmental Origin Central Nervous System Depressants Narcotics Pharmacologic Actions |
Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |