Pregabalin and Orofacial Neuropathic Pain (Pregabalin-Dao)

This study has been terminated.
(difficulty to recruit patients)
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT00852436
First received: November 6, 2008
Last updated: February 15, 2011
Last verified: November 2010

November 6, 2008
February 15, 2011
February 2009
July 2011   (final data collection date for primary outcome measure)
Pain intensity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00852436 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Pregabalin and Orofacial Neuropathic Pain
Efficacy of Pregabalin in the Treatment of Orofacial Neuropathic Pain

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Neuralgia
  • Orofacial Pain
  • 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.
    Other Name: Lyrica
  • 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.
    Other Name: Placebo
  • Active Comparator: 1
    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.
    Intervention: Drug: pregabalin
  • Placebo Comparator: 2
    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.
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
64
August 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00852436
Dao-Watson Pregabalin
No
Thuan Dao, DMD, MSc, PhD, FRCD(C), University of Toronto
University of Toronto
Pfizer
Principal Investigator: Thuan Dao, PhD University of Toronto
University of Toronto
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP