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Pregabalin and Orofacial Neuropathic Pain (Pregabalin-Dao)

Primary Purpose

Neuropathic Pain, Orofacial Pain

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
pregabalin
placebo
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring neuropathic pain, orofacial pain, clinical trials, pregabalin, randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr. P. Watson's office
  • University of Toronto

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain intensity

Secondary Outcome Measures

Pain unpleasantness
Quality of life using the modified short form of Oral health Impact Profile
Anxiety and Depression measured with the Hospital Anxiety and Depression Rating scae
Patient global impression of change
Proportion of patients with 30% and 50% reduction of pain
Side effects

Full Information

First Posted
November 6, 2008
Last Updated
June 1, 2015
Sponsor
University of Toronto
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00852436
Brief Title
Pregabalin and Orofacial Neuropathic Pain
Acronym
Pregabalin-Dao
Official Title
Efficacy of Pregabalin in the Treatment of Orofacial Neuropathic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Terminated
Why Stopped
difficulty to recruit patients
Study Start Date
February 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain, Orofacial Pain
Keywords
neuropathic pain, orofacial pain, clinical trials, pregabalin, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
pregabalin
Other Intervention Name(s)
Lyrica
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Pain unpleasantness
Time Frame
12 weeks
Title
Quality of life using the modified short form of Oral health Impact Profile
Time Frame
12 weeks
Title
Anxiety and Depression measured with the Hospital Anxiety and Depression Rating scae
Time Frame
12 weeks
Title
Patient global impression of change
Time Frame
12 weeks
Title
Proportion of patients with 30% and 50% reduction of pain
Time Frame
2 years
Title
Side effects
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thuan Dao, PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. P. Watson's office
City
Etobicoke
State/Province
Ontario
ZIP/Postal Code
M9V 4B8
Country
Canada
Facility Name
University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1G6
Country
Canada

12. IPD Sharing Statement

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Pregabalin and Orofacial Neuropathic Pain

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