Pregabalin and Orofacial Neuropathic Pain

Neuropathic Pain Clinical Trial

— Pregabalin-Dao  

Official title:

Efficacy of Pregabalin in the Treatment of Orofacial Neuropathic Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00852436
• Other study ID #: Dao-Watson Pregabalin
• Status: Terminated
• Phase: Phase 2
• First received: November 6, 2008
• Last updated: June 1, 2015
• Start date: February 2009
• Est. completion date: October 2010

Study information

• Verified date: November 2010
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Orofacial Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Dr. P. Watson's office	Etobicoke	Ontario
Canada	University of Toronto	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity		12 weeks	No
Secondary	Pain unpleasantness		12 weeks	No
Secondary	Quality of life using the modified short form of Oral health Impact Profile		12 weeks	No
Secondary	Anxiety and Depression measured with the Hospital Anxiety and Depression Rating scae		12 weeks	No
Secondary	Patient global impression of change		12 weeks	No
Secondary	Proportion of patients with 30% and 50% reduction of pain		2 years	No
Secondary	Side effects		12 weeks	Yes