Pregabalin and Orofacial Neuropathic Pain

NCT00852436 | Terminated Phase 2

• 1 other identifier: Dao-Watson Pregabalin
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Neuropathic Pain; Orofacial Pain

Keywords

neuropathic pain; orofacial pain; clinical trials; pregabalin; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  12 weeks

Secondary Outcomes (6)

• Pain unpleasantness

  12 weeks

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

  12 weeks

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

  12 weeks

• Patient global impression of change

  12 weeks

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

  2 years

Study Arms (2)

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

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

Interventions

pregabalin DRUG

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.

Also known as: Lyrica

1

placebo DRUG

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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead
• Pfizer: collaborator

Study Sites (2)

Dr. P. Watson's office

Etobicoke, Ontario, M9V 4B8, Canada

Location

University of Toronto

Toronto, Ontario, M5G1G6, Canada

Location

MeSH Terms

Conditions

Neuralgia; Facial Pain

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Thuan Dao, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 6, 2008
• First Posted: February 27, 2009
• Study Start: February 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: June 3, 2015

Record last verified: 2010-11

Locations

CA (2)