Pregabalin and Orofacial Neuropathic Pain

NCT00852436

Last updated date
Study Location
Dr. P. Watson's office
Etobicoke, Ontario, M9V 4B8, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neuropathic Pain, Orofacial Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Neuropathic Pain, Orofacial PainPregabalin and Orofacial Neuropathic Pain
NCT00852436
  1. Etobicoke, Ontario
  2. Toronto, Ontario
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Pregabalin and Orofacial Neuropathic Pain
Official Title  ICMJE Efficacy of Pregabalin in the Treatment of Orofacial Neuropathic Pain
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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Neuropathic Pain
  • Orofacial Pain
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 1, 2015)
1
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2009)
64
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00852436
Other Study ID Numbers  ICMJE Dao-Watson Pregabalin
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thuan Dao, University of Toronto
Study Sponsor  ICMJE University of Toronto
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Thuan Dao, PhDUniversity of Toronto
PRS Account University of Toronto
Verification Date November 2010

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