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Completed

NCT Number: NCT00407511

Pregabalin Treatment Of Peripheral Neuropathic Pain Associated With Diabetic Peripheral NeP (DPN), Postherpetic Neuralgia (PHN), HIV-related NeP (HIV), and Chemotherapy Induced NeP

Management of neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, human immunodeficiency virus-related peripheral neuropathy, and chemotherapy induced peripheral neuropathy.

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Key information

Conditions

Diabetic Peripheral Neuropathic Pain (DPN) Chemotherapy Induced Neuropathic Pain HIV-related Neuropathic Pain (HIV) Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Postherpetic Neuralgia (PHN) Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Bogota, Cundinamarca, Colombia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who are diagnosed with neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, human immunodeficiency virus related peripheral neuropathy, and chemotherapy induced peripheral neuropathy.

Exclusion criteria

  • Severe Pain associated with conditions other than Diabetic Peripheral Neuropathy, Post-Herpetic Neuralgia, Human Immunodeficiency virus related peripheral neuropathy, and chemotherapy induced peripheral neuropathy that may confound assessment or self evaluation of the neuropathic pain.
  • Skin Condition in the affected dermatome that (in the judgment of the investigator) could alter sensation.

Treatment and study plan

Pregabalin

Drug

Pregabalin will be administered orally, twice a day for 12 weeks, including 4-week dose adjustment phase followed by 8-week maintenance phase. The minimum allowable pregabalin dose during the trial will be 75 mg BID (150 mg/day) and the maximum allowable dose will be 300 mg BID (600 mg/day).

Primary outcomes

  1. Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)

    Time frame: Baseline, End of Treatment

    11 point Likert scale: range 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Final end of treatment (EOT) pain score = mean pain score from last 7 post-Baseline days preceding Visit 8 (Week 12) or last 7 days on study drug for those who did not complete the study. Change = mean at EOT minus mean at Baseline.

Secondary outcomes

  1. Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)

    Time frame: Week 4, Week 8, Week 12

    11 point Likert scale; range: 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Weekly pain score = mean pain score from last 7 post-Baseline days preceding observation visit or last 7 days on study drug for early termination. Change = mean at observation minus mean at Baseline.

  2. Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores

    Time frame: Baseline, Week 8, Week 12, EOT/LOCF

    Self-administered questionnaire: change from Baseline in mean pain severity index over past 24 hours; 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level). Change = mean score at observation minus mean score at Baseline.

  3. Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores

    Time frame: Baseline, Week 8, Week 12, End of Treatment/Last Observation Carried Forward (EOT/LOCF)

    Self-administered questionnaire: change from Baseline in mean pain interference with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. 11-point scale from 0 (does not interfere) to 10 (completely interferes). Change = observation mean minus Baseline mean.

  4. Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication

    Time frame: Baseline, Week 8, Week 12, EOT/LOCF

    Impact of current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=[(5-mean of non-missing items)*100]/4.

  5. Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication

    Time frame: Baseline, Week 8, Week 12, EOT/LOCF

    Satisfaction with current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=[(5-mean of non-missing items)*100]/4.

  6. Change From Baseline in Visual Analogue Scale for Pain (VAS-pain)

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, EOT/LOCF

    100 mm line (Visual Analog Scale) marked by subject; Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain. Change = observation mean minus Baseline mean.

  7. Change From Baseline in Global Anxiety Visual Analogue Scale (GA-VAS)

    Time frame: Baseline, Week 8, Week 12, EOT/LOCF

    100-mm line (Visual Analog Scale) marked by the subject to measure their degree of anxiety over past 24 hours. Range: 0 = not at all anxious to 100 = extremely anxious. Change = mean score at observation minus mean score at Baseline.

  8. Change From Baseline in Mean Daily Sleep Interference Score (DSIS)

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, EOT/LOCF

    Daily sleep interference measured on an 11-point Likert scale. Range: 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). Change = mean at observation minus mean at Baseline. Evaluations recorded in patient's daily sleep diaries.

  9. Patient Global Impression of Change (PGIC)

    Time frame: End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment)

    7-point participant rating scale for change observed in their overall status since beginning of study medication. Range: 1 (very much improved) to 7 (very much worse)

  10. Clinical Global Impression of Change (CGIC)

    Time frame: End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment)

    7-point investigator rating scale of change in participant's status since beginning study medication. Range: 1 (very much improved) to 7 (very much worse).

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

A Prospective, Open Label, Multi-Center, Study Of Pregabalin In The Treatment Of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy, Postherpetic Neuralgia, HIV-Related Peripheral Neuropathic Pain And Chemotherapy Induced Peripheral Neuropathic Pain

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 5, 2006
Registry last updated
Feb 9, 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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