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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

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

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

NCT ID

NCT00852436

First Posted

November 6, 2008

Last Updated

June 1, 2015

Sponsor

University of Toronto

Collaborators

Pfizer

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

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

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

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

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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