Clinical trial NCT00629681: A Study of the Efficacy and Safety of Pregabalin for the Treatment of Diabetic Peripheral Neuropathy or Postherpetic Neuralgia
Official title: Efficacy and Safety of Pregabalin in an Open-label, Non-comparative, Flexible-dose Trial With Diabetic Peripheral Neuropathy or Postherpetic Neuralgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Painful Diabetic Neuropathy and Post Herpetic Neuralgia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-06
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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)


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline to Week 4
Secondary outcomes:
measure: Mean sleep score from patient's daily sleep interference diary
timeFrame: 14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28
measure: Change from baseline in mean sleep score from patient's daily sleep interference diary
timeFrame: End of treatment
measure: Mean anxiety score from patient's daily anxiety diary
timeFrame: 14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28
measure: Adverse events
timeFrame: 14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28
measure: Change from baseline in Pain Treatment Satisfaction Scale (PTSS) 9 items score
timeFrame: End of treatment
measure: Median time to pain response profile
timeFrame: Over the first week
measure: CGIC and PGIC
timeFrame: End of treatment
measure: Change from baseline in EuroQOL (as measures by EQ-5D)
timeFrame: End of treatment
measure: Change from baseline in mean anxiety score from patient's daily anxiety diary
timeFrame: End of treatment
measure: Change from baseline in Medical Outcomes Study (MOS)-Sleep Scale score
timeFrame: End of treatment
measure: Course of mean pain score of patient's daily pain diary (NRS)
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Pfizer Investigational Site
city: Albstadt
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Bielefeld
country: Germany
facility: Pfizer Investigational Site
city: Celle
country: Germany
facility: Pfizer Investigational Site
city: Deggingen
country: Germany
facility: Pfizer Investigational Site
city: Duisburg
country: Germany
facility: Pfizer Investigational Site
city: Erbach
country: Germany
facility: Pfizer Investigational Site
city: Erfurt
country: Germany
facility: Pfizer Investigational Site
city: Frankfurt
country: Germany
facility: Pfizer Investigational Site
city: Gera
country: Germany
facility: Pfizer Investigational Site
city: Goeppingen
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Hemsbach
country: Germany
facility: Pfizer Investigational Site
city: Hildesheim
country: Germany
facility: Pfizer Investigational Site
city: Holle
country: Germany
facility: Pfizer Investigational Site
city: Itzehoe
country: Germany
facility: Pfizer Investigational Site
city: Karlsruhe
country: Germany
facility: Pfizer Investigational Site
city: Karlsruhe
country: Germany
facility: Pfizer Investigational Site
city: Katzhuette
country: Germany
facility: Pfizer Investigational Site
city: Leer
country: Germany
facility: Pfizer Investigational Site
city: Leipzig
country: Germany
facility: Pfizer Investigational Site
city: Limburgerhof
country: Germany
facility: Pfizer Investigational Site
city: Ludwigshafen
country: Germany
facility: Pfizer Investigational Site
city: Ludwigshafen
country: Germany
facility: Pfizer Investigational Site
city: Luebeck
country: Germany
facility: Pfizer Investigational Site
city: Luenen
country: Germany
facility: Pfizer Investigational Site
city: Mainz
country: Germany
facility: Pfizer Investigational Site
city: Marl
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Muenster
country: Germany
facility: Pfizer Investigational Site
city: Osnabrueck
country: Germany
facility: Pfizer Investigational Site
city: Recklinghausen
country: Germany
facility: Pfizer Investigational Site
city: Senftenberg
country: Germany
facility: Pfizer Investigational Site
city: Sinsheim
country: Germany
facility: Pfizer Investigational Site
city: Surwold
country: Germany
facility: Pfizer Investigational Site
city: Unterhaching
country: Germany
facility: Pfizer Investigational Site
city: Veitsbronn
country: Germany
facility: Pfizer Investigational Site
city: Weimar
country: Germany
facility: Pfizer Investigational Site
city: Wiesbaden
country: Germany
facility: Pfizer Investigational Site
city: Witten
country: Germany
facility: Pfizer Investigational Site
city: Zwoenitz
country: Germany
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: