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Completed

NCT Number: NCT00219544

Efficacy Study Measuring the Impact of Pregabalin on 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).

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Key information

Conditions

Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pregabalin (Lyrica)

Drug

pregabalin 150mg/day (75mg BID)

Placebo

Drug

Placebo

Primary outcomes

  1. Neuropathic Pain in Subjects With Peripheral Neuropathic Pain Conditions During the Double-blind Phase

    Time frame: 9 weeks

    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").

Secondary outcomes

  1. Weekly Mean Pain Scores During the Single-blind Treatment Phase

    Time frame: 0 and 4 weeks

    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").

  2. Weekly Mean Pain Scores During the Double Blind Treatment Phase

    Time frame: Week 4 - 9

    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").

  3. Change in Pain Scores During Double Blind Treatment Phase

    Time frame: 9 weeks

    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").

  4. Number of Subjects With >= 30% Reduction in Mean Pain Score During Single-blind Treatment

    Time frame: Week 4 (end of single-blind treatment phase)

    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").

  5. 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.

    Time frame: Week 4

    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.

  6. Mean Pain Score for Non-responders at End of Single-blind Treatment Phase

    Time frame: Week 4

    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.

  7. Categorized Daily Pain Score

    Time frame: Week 9

    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)

  8. Time to Meaningful Increase in Pain During Double-blind Treatment Phase (Number of Participants)

    Time frame: Week 9

    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 .

  9. Mean Sleep Interference Score

    Time frame: Week 9

    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."

  10. Weekly Mean Sleep Interference Scores During the Single-Blind Treatment Phase

    Time frame: 0 and 4 weeks

    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."

  11. Weekly Mean Sleep Interference Scores During the Double Blind Treatment Phase

    Time frame: Week 9

    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."

  12. Change in Sleep Interference Scores During Double Blind Treatment Phase

    Time frame: 9 weeks

    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."

  13. Intensity of Neuropathic Pain -Visual Analog Scale (NeP - VAS)

    Time frame: Week 4, Week 9

    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.

  14. Change in Hospital Anxiety and Depression Scale Responses

    Time frame: Week 9

    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.

  15. Change in Pain Treatment Satisfaction Scale (PTSS)

    Time frame: Week 9

    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.

  16. Patient Global Impression of Change (PGIC) Categories by Number of Subjects

    Time frame: Week 9

    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).

  17. Change in Modified Brief Pain Inventory (mBPI) for Pain Interference or Pain Severity.

    Time frame: Week 9

    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.

  18. Change in Euro Quality of Life (EQ-5D) Health State Profile and Visual Analog Scale Components

    Time frame: Week 9

    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)

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 22, 2005
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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