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Pregabalin and Orofacial Neuropathic Pain

Information source: University of Toronto
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neuropathic Pain; Orofacial Pain

Intervention: pregabalin (Drug); placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Toronto

Official(s) and/or principal investigator(s):
Thuan Dao, PhD, Principal Investigator, Affiliation: University of Toronto

Overall contact:
Thuan Dao, PhD, Phone: 416 979 4930, Ext: 4338, Email: thuan.dao@utoronto.ca

Summary

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

Clinical Details

Official title: Efficacy of Pregabalin in the Treatment of Orofacial Neuropathic Pain

Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Pain intensity

Secondary outcome:

Pain unpleasantness

Quality of life using the modified short form of Oral health Impact Profile

Anxiety and Depression measured with the Hospital Anxiety and Depression Rating scae

Patient global impression of change

Proportion of patients with 30% and 50% reduction of pain

Side effects

Detailed description: 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients 18 years of age or older, males and females

- history of dental and/or maxillofacial treatment/surgery that may cause nerve injury

(e. g. root canal treatment, implant placement, deep restorations, tooth extractions, injection of anesthetics)

- patients who score 12 on the validated self-report version of the Leeds Assessment of

Neuropathic Symptoms and Signs pain scale (S-LANSS; Bennett et al. 2005) for extra-oral sites, or 9 for intra-oral sites (the scoring for extra-oral sites is taken as suggested; for intra-oral sites, the 5-point scoring for question 2 has been removed and the score proportionally adjusted, since it is difficult for patients to see color changes in their mouth)

- pain rated 4 or more on a numerical scale (0 being no pain, 10 being the most intense

pain imaginable), on a daily basis

- pain lasting more than 6 months

- absence of identifiable organic lesion, inflammation or infection

- normal serum creatinine

- reports that current and previous pain medications failed to provide adequate relief

(e. g., analgesic, non-steroidal anti-inflammatories, opioids, antidepressants)

- if currently using medication, acceptance of a wash-out period of at least one week,

during which only Tylenol can be used as rescue medication

- able to use the Palm handheld device to report daily pain

Exclusion Criteria:

- lactating, pregnancy (potentially child bearing patients need to have a referral from

family physician stating that the patient is not expecting or to be using contraception)

- renal impairment or renal failure (contra-indication to pregabalin)

- congestive heart failure or liver disease

- currently suffering from trigeminal neuralgia

- history of mental disorder, widespread pain or other severe pain conditions that may

confound the pain assessment (e. g. depression, chronic fatigue, migraine headaches, fibromyalgia, severe chronic pain conditions)

- intolerance or allergy to gabapentin and pregabalin

Locations and Contacts

Thuan Dao, PhD, Phone: 416 979 4930, Ext: 4338, Email: thuan.dao@utoronto.ca

Dr. P. Watson's office, Etobicoke, Ontario M9V 4B8, Canada; Recruiting
Peter Watson, MD, Phone: 416 239 3494, Email: peter.watson@utoronto.ca
Peter Watson, PhD, Principal Investigator

University of Toronto, Toronto, Ontario M5G1G6, Canada; Recruiting
Thuan Dao, PhD, Phone: 416 979 4930, Ext: 4338, Email: thuan.dao@utoronto.ca
Thuan Dao, PhD, Principal Investigator

Additional Information

Starting date: February 2009
Last updated: April 14, 2010

Page last updated: October 04, 2010

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