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

Phase 3CompletedNCT00219544

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.158 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

158

Conditions

Neuropathic Pain

Interventions

Pregabalin (Lyrica)DRUG

pregabalin 150mg/day (75mg BID)

Pregabalin (Lyrica)DRUG

pregabalin 300 mg/day (150mg BID)

Pregabalin (Lyrica)DRUG

pregabalin 600/day (300mg BID)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (30)

Outcomes

Primary Outcomes

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").

Time frame: 9 weeks

Secondary Outcomes

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").

Time frame: 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").

Time frame: 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").

Time frame: 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").

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Calgary, Alberta, Canada

Pfizer Investigational Site

Calgary, Alberta, Canada

Pfizer Investigational Site

Calgary, Alberta, Canada

Pfizer Investigational Site

Edmonton, Alberta, Canada

Pfizer Investigational Site

Edmonton, Alberta, Canada

Pfizer Investigational Site

Red Deer, Alberta, Canada

Pfizer Investigational Site

Kelowna, British Columbia, Canada

Pfizer Investigational Site

Vancouver, British Columbia, Canada

Pfizer Investigational Site

Vancouver, British Columbia, Canada

Pfizer Investigational Site

Winnipeg, Manitoba, Canada

...and 20 more locations

Time frame: 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.

Time frame: 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.

Time frame: 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)

Time frame: 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 .

Time frame: 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."

Time frame: 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."

Time frame: 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."

Time frame: 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."

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: 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)

Time frame: Week 9