Efficacy Study Measuring the Impact of Pregabalin on Peripheral Neuropathic Pain.

A Randomized, Placebo-Controlled Trial of the Efficacy and Safety of Pregabalin in the Treatment of Subjects With Peripheral Neuropathic Pain

This study will measure the impact of treatment with pregabalin in adult men and women who have a diagnosis of peripheral neuropathic pain (pain caused by a primary lesion of the peripheral nervous system such as Diabetic peripheral Neuropathy and Postherpetic Neuralgia).

Study Overview

• Status: Completed
• Conditions: Neuropathic Pain
• Intervention / Treatment: Drug: Placebo; Drug: Pregabalin (Lyrica); Drug: Pregabalin (Lyrica); Drug: Pregabalin (Lyrica)

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • Pfizer Investigational Site
    • Calgary, Alberta, Canada, T3B 0M3
      • Pfizer Investigational Site
    • Calgary, Alberta, Canada, T2S 3C3
      • Pfizer Investigational Site
    • Edmonton, Alberta, Canada, T5J 3N4
      • Pfizer Investigational Site
    • Edmonton, Alberta, Canada, T5N 3Y6
      • Pfizer Investigational Site
    • Red Deer, Alberta, Canada, T4N 6V7
      • Pfizer Investigational Site
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 2H4
      • Pfizer Investigational Site
    • Vancouver, British Columbia, Canada, V6Z 2E8
      • Pfizer Investigational Site
    • Vancouver, British Columbia, Canada, V6E 1M7
      • Pfizer Investigational Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Pfizer Investigational Site
    • Winnipeg, Manitoba, Canada, R3E 3P4
      • Pfizer Investigational Site
    • Winnipeg, Manitoba, Canada, R2V 4W3
      • Pfizer Investigational Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3J 3T1
      • Pfizer Investigational Site
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Pfizer Investigational Site
    • London, Ontario, Canada, N6A 4V2
      • Pfizer Investigational Site
    • Port Hope, Ontario, Canada, L1A 3Y9
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M5G 2N2
      • Pfizer Investigational Site
  • Prince Edward Island
    • Charlottetown, Prince Edward Island, Canada, C1E 1J7
      • Pfizer Investigational Site
  • Quebec
    • Granby, Quebec, Canada, J2G 8Z9
      • Pfizer Investigational Site
    • Laval, Quebec, Canada, H7T 2P5
      • Pfizer Investigational Site
    • Laval, Quebec, Canada, H7M 3L9
      • Pfizer Investigational Site
    • Levis, Quebec, Canada, G6V 3Z1
      • Pfizer Investigational Site
    • Mirabel, Quebec, Canada, J7J 2K8
      • Pfizer Investigational Site
    • Montreal, Quebec, Canada, H3G 1A4
      • Pfizer Investigational Site
    • Montreal, Quebec, Canada, H3T 1E2
      • Pfizer Investigational Site
    • Montreal, Quebec, Canada, H3A 2B4
      • Pfizer Investigational Site
    • Sherbrook, Quebec, Canada, J1H 4J6
      • Pfizer Investigational Site
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Pfizer Investigational Site
    • Ste-Foy, Quebec, Canada, G1V 4X7
      • Pfizer Investigational Site
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects presenting a diagnosis of peripheral neuropathic pain, defined as pain caused by a lesion of the peripheral nervous system manifesting with sensory symptoms and signs, for at least 6 months at screening.
• At baseline, subjects must have completed at least 4 daily pain diaries and must have a mean weekly pain score equal or greater than 4.

Exclusion Criteria:

• Presence of any of the following diagnoses: Cervical or lumbo-sacral radiculopathy; Operated or non-operated chronic low back pain Carpal tunnel syndrome or any other entrapment-related neuropathic pain (defined as pain associated with focal nerve lesion produced by constriction or mechanical distortion of the nerve, within a fibrous or fibro-osseous tunnel, or by a fibrous band) ; Complex regional pain syndrome (type 1 and 2); Fibromyalgia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1	Drug: Pregabalin (Lyrica); pregabalin 150mg/day (75mg BID); Drug: Pregabalin (Lyrica); pregabalin 300 mg/day (150mg BID); Drug: Pregabalin (Lyrica); pregabalin 600/day (300mg BID)
EXPERIMENTAL: 2	Drug: Pregabalin (Lyrica); pregabalin 150mg/day (75mg BID); Drug: Pregabalin (Lyrica); pregabalin 300 mg/day (150mg BID); Drug: Pregabalin (Lyrica); pregabalin 600/day (300mg BID)
EXPERIMENTAL: 3	Drug: Pregabalin (Lyrica); pregabalin 150mg/day (75mg BID); Drug: Pregabalin (Lyrica); pregabalin 300 mg/day (150mg BID); Drug: Pregabalin (Lyrica); pregabalin 600/day (300mg BID)
PLACEBO_COMPARATOR: 4	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropathic Pain in Subjects With Peripheral Neuropathic Pain Conditions During the Double-blind Phase	Pain score end of Double-Blind treatment = mean of last 7 available pain scores from daily pain diary while on Double-Blind treatment. A Daily Pain Rating Score : 11- point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain").	9 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weekly Mean Pain Scores During the Single-blind Treatment Phase	Pain score at Week 0 and Week 4, end of single-bind treatment. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11- point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain").	0 and 4 weeks
Weekly Mean Pain Scores During the Double Blind Treatment Phase	Mean Pain scores for weeks 4, 5, 6, 7, 8 and 9. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain").	Week 4 - 9
Change in Pain Scores During Double Blind Treatment Phase	Change in Mean Pain score = Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain").	9 weeks
Number of Subjects With >= 30% Reduction in Mean Pain Score During Single-blind Treatment	Responders = ≥30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain").	Week 4 (end of single-blind treatment phase)
Mean Pain Score for Responders at End of Single-blind Treatment Phase. Change From Baseline of Mean of Last 7 Available Pain Scores From Daily Pain Diary While on Single-blind Treatment.	Daily Pain Rating Score:11-point numerical scale 0 ("no pain") to 10 ("worst possible pain"). Responders = ≥30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline.	Week 4
Mean Pain Score for Non-responders at End of Single-blind Treatment Phase	Change from baseline of mean of last 7 available pain scores from daily pain diary while on single-blind treatment. Daily Pain Rating Score:11-point numerical scale 0 ("no pain") to 10 ("worst possible pain"). Non-Responders = <30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline.	Week 4
Categorized Daily Pain Score	Mean number of days in each pain category. DPRS Daily Pain Rating Score Categories: No pain (score 0), Mild pain (scores 1-3), Moderate pain (scores 4-6), Severe pain (scores 7-10)	Week 9
Time to Meaningful Increase in Pain During Double-blind Treatment Phase (Number of Participants)	Number of participants who experienced a meaningful increase in pain also includes participants who took rescue medication for pain due to peripheral neuropathic pain or discontinued from the study .	Week 9
Mean Sleep Interference Score	Mean Sleep Interference (SI) score at end of Double-Blind treatment = mean of last 7 available SI scores from daily SI diary while on Double-Blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means "pain does not interfere with sleep" and 10 means "pain completely interferes with sleep."	Week 9
Weekly Mean Sleep Interference Scores During the Single-Blind Treatment Phase	Sleep Interference (SI) score at Week 0 and Week 4, end of single-bind treatment. Mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means "pain does not interfere with sleep" and 10 means "pain completely interferes with sleep."	0 and 4 weeks
Weekly Mean Sleep Interference Scores During the Double Blind Treatment Phase	Mean Sleep Interference scores for weeks 4, 5, 6, 7, 8 and 9. Mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means "pain does not interfere with sleep" and 10 means "pain completely interferes with sleep."	Week 9
Change in Sleep Interference Scores During Double Blind Treatment Phase	Change in Mean SI score: Mean SI score at observation minus mean SI score at week 4. Mean SI Score = mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) is 11-point numerical scale : Zero means "pain does not interfere with sleep" and 10 means "pain completely interferes with sleep."	9 weeks
Intensity of Neuropathic Pain -Visual Analog Scale (NeP - VAS)	Change in Scale from randomization to Week 9. Scale to measure Neuropathic Pain -Visual Analog Scale (NeP - VAS): the subject places a mark on the VAS scale (0 to 100) where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.	Week 4, Week 9
Change in Hospital Anxiety and Depression Scale Responses	Mean Change from Randomization in Score from Hospital Anxiety and Depression Scale (HADS): 2 subscales, measuring anxiety (HADS-A)and depression (HADS-D). 7 items in each subscale assessed on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). which yields the score ranging 0-21.	Week 9
Change in Pain Treatment Satisfaction Scale (PTSS)	Mean Change: score from observation minus score from randomization: PTSS "Impact" module of 8-items & "Satisfaction" module of 6-items; item scores 1-5. Mean score for each module transformed onto scale 0- 100, where score 0 =worst possible response and score 100 =best possible response: Score =[(5 - mean non-missing items)*100]/4.	Week 9
Patient Global Impression of Change (PGIC) Categories by Number of Subjects	Number of subjects that responded to PGIC Categories. PGIC is a subject-rated instrument that measures change in the subject's overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse).	Week 9
Change in Modified Brief Pain Inventory (mBPI) for Pain Interference or Pain Severity.	Mean Change from Randomization: score at mBPI observation minus score at randomization. mBPI is extent to which pain interferes with daily activities on a 0 (no interference) to 10 (completely interfered) scale.	Week 9
Change in Euro Quality of Life (EQ-5D) Health State Profile and Visual Analog Scale Components	two components to the EQ-5D: a Health State Profile (scores from five domains are used to calculate the utility score :0 refers to dead and a score of 1 refers to perfect health) and a Visual Analogue Scale (VAS) (0 represents the worst imaginable health state and 100 represents the best imaginable health state)	Week 9

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (ACTUAL): February 1, 2008
• Study Completion (ACTUAL): February 1, 2008

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (ESTIMATE): September 22, 2005

Study Record Updates

• Last Update Posted (ACTUAL): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 20, 2021
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: A0081084