Pregabalin and Orofacial Neuropathic Pain - Full Text View

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

Resource links provided by NLM:

Drug Information available for: Pregabalin

U.S. FDA Resources

Further study details as provided by University of Toronto:

Primary Outcome Measures:

Pain intensity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain unpleasantness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Quality of life using the modified short form of Oral health Impact Profile [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Anxiety and Depression measured with the Hospital Anxiety and Depression Rating scae [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Patient global impression of change [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Proportion of patients with 30% and 50% reduction of pain [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Side effects [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

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.

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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852436

Contacts

Contact: Thuan Dao, PhD

416 979 4930 ext 4338

thuan.dao@utoronto.ca

Locations

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

Sponsors and Collaborators

University of Toronto

Pfizer

Investigators

Principal Investigator:

Thuan Dao, PhD

University of Toronto

More Information

No publications provided

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

Keywords provided by University of Toronto:

neuropathic pain
orofacial pain
clinical trials
pregabalin
randomized controlled trial

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on February 08, 2010