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Completed

NCT Number: NCT00629681

A Study of the Efficacy and Safety of Pregabalin for the Treatment of Diabetic Peripheral Neuropathy or Postherpetic Neuralgia

The purpose of this study is to assess the efficacy and safety of pregabalin for the treatment of diabetic peripheral neuropathy (DPN) or postherpetic neuralgia (PHN)

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Key information

Conditions

Painful Diabetic Neuropathy and Post Herpetic Neuralgia Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuralgia Neuralgia, Postherpetic 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 4

Primary location

Pfizer Investigational Site, Aachen, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of DPN or PHN
  • Score on the Numeric Rating Scale of at least 4/10

Exclusion criteria

  • Hospitalized patients
  • Neurologic disorders unrelated to DPN or PHN or any severe pain that may confound the assessment of DPN- or PHN-related pain

Treatment and study plan

Pregabalin

Drug

Pregabalin capsules; initial dose of 75 mg twice daily for 4 days. Dose could be increased based on individual patient's response and tolerability to 150 mg twice daily from Day 4 onwards, with a further increase to 300 mg twice daily from Day 14 onwards if needed. Total duration of treatment was 28 days.

Primary outcomes

  1. Correlation between global status (as measured by the Clinical Global Impression of Change [CGIC] and the Patient Global Impression of Change [PGIC]) and changes in pain, anxiety, and sleep parameters

    Time frame: Baseline to Week 4

Secondary outcomes

  1. Mean sleep score from patient's daily sleep interference diary

    Time frame: 14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28

  2. Change from baseline in mean sleep score from patient's daily sleep interference diary

    Time frame: End of treatment

  3. Mean anxiety score from patient's daily anxiety diary

    Time frame: 14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28

  4. Adverse events

    Time frame: 14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28

  5. Change from baseline in Pain Treatment Satisfaction Scale (PTSS) 9 items score

    Time frame: End of treatment

  6. Median time to pain response profile

    Time frame: Over the first week

  7. CGIC and PGIC

    Time frame: End of treatment

  8. Change from baseline in EuroQOL (as measures by EQ-5D)

    Time frame: End of treatment

  9. Change from baseline in mean anxiety score from patient's daily anxiety diary

    Time frame: End of treatment

  10. Change from baseline in Medical Outcomes Study (MOS)-Sleep Scale score

    Time frame: End of treatment

  11. Course of mean pain score of patient's daily pain diary (NRS)

    Time frame: Throughout the study

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

Efficacy and Safety of Pregabalin in an Open-label, Non-comparative, Flexible-dose Trial With Diabetic Peripheral Neuropathy or Postherpetic Neuralgia

Important dates

Study start
2004
Study completion
2006
First posted
Mar 6, 2008
Registry last updated
Jan 25, 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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