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Sponsors and Collaborators: |
Wex Pharmaceuticals Inc. Multicentre |
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Information provided by: | Wex Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT00726011 |
Different pathophysiologic mechanisms are responsible for the development of chronic pain disorders. Pain pathways are triggered in part by ectopic discharges of voltage-sensitive sodium channels, which are in abundance in both the peripheral and the central nervous systems. Tetrodotoxin (TTX) is a selective blocker of Na+ channels and causes analgesia either by decreasing the propagation of action potentials by Na+ channels and/or by blocking of ectopic discharges associated with chronic pain.
Tectin™ is an injectable formulation of TTX extracted from the puffer fish (fugu). Results from animal pharmacology studies revealed that Tectin™ is a more potent analgesic than standard analgesic agents such as aspirin, morphine or meperidine.
At present, the management of severe cancer pain generally includes the use of opiates. This can often result in undesirable side effects, and treatment with this type of medication is not always effective. Because currently available pain-relieving therapy is unsatisfactory for many patients, there is a need for new therapeutic approaches for the management of moderate or severe cancer pain.
Recent studies indicate that intramuscular (into a muscle) or subcutaneous (under the skin) injections of tetrodotoxin (Tectin) may reduce pain in cancer patients who did not respond to standard therapies.
The current proposed study (TEC-006OL) is designed to provide the option for all patients who participated in the TEC-006 study (both tetrodotoxin and placebo-treated) to receive or continue to receive tetrodotoxin treatment.
Condition | Intervention | Phase |
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Pain Cancer |
Biological: Tetrodotoxin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicentre, Open-Label, Long-Term Efficacy and Safety Continuation Study of Subcutaneous Tetrodotoxin (Tectin™) for Moderate to Severe Cancer-Related Pain |
Estimated Enrollment: | 120 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All patients who participated in the TEC-006 study (tetrodotoxin and placebo-treated) will be eligible for inclusion in this study provided they wish to continue to receive treatment and meet the inclusion and exclusion criteria.
NOTE: The blinded treatment assignment of patients in the TEC-006 will not be revealed to either the investigator or the patient. Patients will not be aware which treatment they received in the TEC-006 study. All patients will receive tetrodotoxin treatment in the TEC-006OL study.
A patient will be eligible or continue to be eligible for inclusion in this study (First Treatment Cycle and subsequent Treatment Cycles) only if all of the following criteria apply:
Exclusion Criteria:
A patient will not be eligible for inclusion in this study if any of the following criteria apply:
Contact: Donna Shum | 604-676-7896 | donnas@wexpharma.com |
Canada, British Columbia | |
WEX Pharmaceuticals Inc. | Recruiting |
Vancouver, British Columbia, Canada, V6C 1G8 | |
Contact: Donna Shum 604-676-7896 donnas@wexpharma.com |
Study Chair: | Dr. Neil Hagen, MD, FRCPC | Tom Baker Cancer Centre |
Study Director: | Dr. Jean Bourgouin, MD, CSO | Wex Pharmaceuticals Inc. |
Responsible Party: | WEX Pharmaceuticals Inc. ( Jean Bourgouin, MD, Chief Scientific Officer ) |
Study ID Numbers: | TEC-006OL |
Study First Received: | July 28, 2008 |
Last Updated: | July 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00726011 |
Health Authority: | BGTD (Biologics & Genetics and Therapies Directorate): Health Canada |
due cancer treatment |
Tetrodotoxin Pain |
Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Cardiovascular Agents Pharmacologic Actions Anesthetics, Local |
Membrane Transport Modulators Sensory System Agents Therapeutic Uses Sodium Channel Blockers Peripheral Nervous System Agents Central Nervous System Agents |