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

Painful Diabetic Neuropathy and Post Herpetic Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00629681
• Other study ID #: A0081031
• Status: Completed
• Phase: Phase 4
• Start date: November 2004
• Est. completion date: February 2006

Study information

• Verified date: April 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Neuralgia
• Neuralgia, Postherpetic
• Painful Diabetic Neuropathy and Post Herpetic Neuralgia
• Peripheral Nervous System Diseases

Intervention

Drug:
• Pregabalin
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.

Locations

Country	Name	City	State
Germany	Pfizer Investigational Site	Aachen
Germany	Pfizer Investigational Site	Albstadt
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Bielefeld
Germany	Pfizer Investigational Site	Celle
Germany	Pfizer Investigational Site	Deggingen
Germany	Pfizer Investigational Site	Duisburg
Germany	Pfizer Investigational Site	Erbach
Germany	Pfizer Investigational Site	Erfurt
Germany	Pfizer Investigational Site	Frankfurt
Germany	Pfizer Investigational Site	Gera
Germany	Pfizer Investigational Site	Goeppingen
Germany	Pfizer Investigational Site	Hamburg
Germany	Pfizer Investigational Site	Hamburg
Germany	Pfizer Investigational Site	Hamburg
Germany	Pfizer Investigational Site	Hemsbach
Germany	Pfizer Investigational Site	Hildesheim
Germany	Pfizer Investigational Site	Holle
Germany	Pfizer Investigational Site	Itzehoe
Germany	Pfizer Investigational Site	Karlsruhe
Germany	Pfizer Investigational Site	Karlsruhe
Germany	Pfizer Investigational Site	Katzhuette
Germany	Pfizer Investigational Site	Leer
Germany	Pfizer Investigational Site	Leipzig
Germany	Pfizer Investigational Site	Limburgerhof
Germany	Pfizer Investigational Site	Ludwigshafen
Germany	Pfizer Investigational Site	Ludwigshafen
Germany	Pfizer Investigational Site	Luebeck
Germany	Pfizer Investigational Site	Luenen
Germany	Pfizer Investigational Site	Mainz
Germany	Pfizer Investigational Site	Marl
Germany	Pfizer Investigational Site	Muenchen
Germany	Pfizer Investigational Site	Muenster
Germany	Pfizer Investigational Site	Osnabrueck
Germany	Pfizer Investigational Site	Recklinghausen
Germany	Pfizer Investigational Site	Senftenberg
Germany	Pfizer Investigational Site	Sinsheim
Germany	Pfizer Investigational Site	Surwold
Germany	Pfizer Investigational Site	Unterhaching
Germany	Pfizer Investigational Site	Veitsbronn
Germany	Pfizer Investigational Site	Weimar
Germany	Pfizer Investigational Site	Wiesbaden
Germany	Pfizer Investigational Site	Witten
Germany	Pfizer Investigational Site	Zwoenitz

Sponsors (1)

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

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Baseline to Week 4
Secondary	Mean sleep score from patient's daily sleep interference diary		14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28
Secondary	Change from baseline in mean sleep score from patient's daily sleep interference diary		End of treatment
Secondary	Mean anxiety score from patient's daily anxiety diary		14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28
Secondary	Adverse events		14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28
Secondary	Change from baseline in Pain Treatment Satisfaction Scale (PTSS) 9 items score		End of treatment
Secondary	Median time to pain response profile		Over the first week
Secondary	CGIC and PGIC		End of treatment
Secondary	Change from baseline in EuroQOL (as measures by EQ-5D)		End of treatment
Secondary	Change from baseline in mean anxiety score from patient's daily anxiety diary		End of treatment
Secondary	Change from baseline in Medical Outcomes Study (MOS)-Sleep Scale score		End of treatment
Secondary	Course of mean pain score of patient's daily pain diary (NRS)		Throughout the study

External Links

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