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Sponsors and Collaborators: |
Ludwig-Maximilians - University of Munich German Federal Ministry of Education and Research German Research Network on Neuropathic Pain |
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Information provided by: | Ludwig-Maximilians - University of Munich |
ClinicalTrials.gov Identifier: | NCT00377468 |
The purpose of this study is to determine whether application of low dose Delta9-Tetrahydrocannabinol can prevent the development of chronic pain in patients with acute CRPS.
Condition | Intervention | Phase |
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Complex Regional Pain Syndromes CRPS |
Drug: Delta9-Tetrahydrocannabinol |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Low Dose Administration of Delta9-Tetrahydrocannabinol for the Prevention of Hyperalgesia and Chronic Pain in Patients With Acute Complex Regional Pain Syndrome (CRPS) of the Upper Limb |
Estimated Enrollment: | 100 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | December 2008 |
Recent animal data suggest that the endocannabinoid system is a promising target in the prevention of chronic pain. It has been shown that the endocannabinoid system modifies excitatory and inhibitory currents in structures involved in the development of chronic pain such as the amygdala.
CRPS is a neuropathic pain condition, which is known to become chronic in a significant percentage. The study compares the effect of low dose Delta9-Tetrahydrocannabinol (90 days) and placebo in acute CRPS. All patients will receive a standard treatment consisting of drug therapy and physiotherapy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Meike Lauchart, MD | +49897095 ext 4464 | Meike.Lauchart@med.uni-muenchen.de |
Contact: Volker Huge, MD | +49897095 ext 4464 | Volker.Huge@med.uni-muenchen.de |
Germany | |
Department of Anesthesiology, Interdisciplinary Pain Clinic Grosshadern, Universitiy of Munich | Recruiting |
Munich, Germany, 81377 |
Principal Investigator: | Shahnaz C Azad, MD;PhD | Department of Anesthesiology, Interdisciplinary Pain Clinic Grosshadern, University of Munich |
Study ID Numbers: | 2310106, Eudra-CT: 2006-000439-85 |
Study First Received: | September 14, 2006 |
Last Updated: | June 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00377468 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
THC CRPS Pain Complex Regional Pain Syndrome |
Neuropathic Pain Chronic Prevention |
Tetrahydrocannabinol Autonomic Nervous System Diseases Neuromuscular Diseases Complex Regional Pain Syndromes |
Peripheral Nervous System Diseases Pain Hyperalgesia |
Disease Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Hallucinogens Pharmacologic Actions Pathologic Processes |
Analgesics, Non-Narcotic Sensory System Agents Syndrome Therapeutic Uses Peripheral Nervous System Agents Analgesics Central Nervous System Agents |