|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | University of Toronto |
|---|---|
| Collaborator: |
Pfizer |
| Information provided by: | University of Toronto |
| ClinicalTrials.gov Identifier: | NCT00852436 |
Purpose
The purpose of this study is to determine whether pregabalin can decrease pain and improve quality of life in patients who have nerve pain on the mouth or the face
| Condition | Intervention | Phase |
|---|---|---|
|
Neuropathic Pain Orofacial Pain |
Drug: pregabalin Drug: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Efficacy of Pregabalin in the Treatment of Orofacial Neuropathic Pain |
| Estimated Enrollment: | 64 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Pregabalin capsules in 75 mg, administered orally one (or two, or four) capsule(s), twice daily. Dosing increment from 150, 300, to 600mg/day at weekly intervals.
|
Drug: pregabalin
Pregabalin capsules in 75 mg,dosing increment from 150, 300, to 600mg/day at weekly intervals,administered orally one (or two, or four) capsule(s), twice daily. Fixed schedule of dosing increment from 150, 300, to 600mg/day at weekly intervals, until the highest tolerated dose has been reached. A single downward dose titration will be allowed depending on tolerability, after which the patient will remain on this dosage for the rest of the study.
|
|
2: Placebo Comparator
Placebo capsules in 75 mg, administered orally one (or two, or four) capsule(s), twice daily. Dosing increment from 150, 300, to 600mg/day at weekly intervals.
|
Drug: placebo
Placebo capsules in 75 mg,dosing increment from 150, 300, to 600mg/day at weekly intervals,administered orally one (or two, or four) capsule(s), twice daily. Fixed schedule of dosing increment from 150, 300, to 600mg/day at weekly intervals, until the highest tolerated dose has been reached. A single downward dose titration will be allowed depending on tolerability, after which the patient will remain on this dosage for the rest of the study.
|
Neuropathic pain (NP) is defined as pain initiated or caused by a primary lesion or dysfunction in the nervous system. At the trigeminal area where somatosensory nerves are often damaged during dental /maxillofacial interventions, post-operative orofacial neuropathic pain (OFNP) estimated treated prevalence/incidence rates were ~3-12%, with 83% of patients reporting that OFNP started with a dental treatment. Although OFNP is a burden for the society, and a major cause of chronic distress, disability and expenditure of medical resources, clinical trials that assess efficacy of its treatment are scarce. Until today, treatments of OFNP are extrapolated from those issued for neuropathic pain in other body sites. This clinical trial will be the first to evaluate the efficacy, safety, and tolerance of pregabalin in the treatment of OFNP. Based on the results obtained for neuropathic pain on non trigeminal areas, we expect to see positive results, and to provide evidence for effective management of OFNP with an anticonvulsant such as pregabalin.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Thuan Dao, PhD | 416 979 4930 ext 4338 | thuan.dao@utoronto.ca |
| Canada, Ontario | |
| Dr. P. Watson's office | Recruiting |
| Etobicoke, Ontario, Canada, M9V 4B8 | |
| Contact: Peter Watson, MD 416 239 3494 peter.watson@utoronto.ca | |
| Principal Investigator: Peter Watson, PhD | |
| University of Toronto | Recruiting |
| Toronto, Ontario, Canada, M5G1G6 | |
| Contact: Thuan Dao, PhD 416 979 4930 ext 4338 thuan.dao@utoronto.ca | |
| Principal Investigator: Thuan Dao, PhD | |
| Principal Investigator: | Thuan Dao, PhD | University of Toronto |
More Information
| Responsible Party: | University of Toronto ( Thuan Dao, DMD, MSc, PhD, FRCD(C) ) |
| Study ID Numbers: | Dao-Watson Pregabalin |
| Study First Received: | November 6, 2008 |
| Last Updated: | February 26, 2009 |
| ClinicalTrials.gov Identifier: | NCT00852436 History of Changes |
| Health Authority: | Canada: Health Canada |
|
neuropathic pain orofacial pain clinical trials pregabalin randomized controlled trial |
|
Facial Pain Neuralgia Nervous System Diseases Physiological Effects of Drugs Pregabalin Pain Pharmacologic Actions Signs and Symptoms Neuromuscular Diseases |
Sensory System Agents Therapeutic Uses Peripheral Nervous System Diseases Neurologic Manifestations Analgesics Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |