Clinical trial NCT00644748: A Study on the Efficacy and Safety of Gabapentin in the Treatment of Patients With Painful Diabetic Neuropathy
Official title: An Open, Multicenter Study on the Efficacy, Safety and Tolerability of Gabapentin, Titrated for Reaching an Effect for the Treatment of the Painful Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Neuropathies
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 95
Sex: ALL
Minimum age (years): 51
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 was to evaluate the efficacy, safety, and tolerability of gabapentin for the treatment of patients with painful diabetic neuropathy. The quality of life of all treated patients was also assessed.


Eligibility criteria: Inclusion Criteria:

* Patients with stable Diabetes Mellitus 1 or 2
* Clinical diagnosis of distal symmetric polyneuropathy with a minimum duration of 8 weeks
* No clinically significant motor deficits
* Pain described according to at least one of the following clinical manifestations: burning, cramps or twinges, thermal or mechanical alodinea

Exclusion Criteria:

* Treatment with any medication that may interfere with the assessment of gabapentin during the study or within 7 days of the adminstration of gabapentin
* Specific systemic diseases or other medical conditions that would interfere with the assessment of gabapentin therapeutic response or safety

Primary outcomes:
measure: Change from baseline Mean Pain Score
timeFrame: Endpoint
Secondary outcomes:
measure: Change from baseline Mean Pain Score
timeFrame: Weekly
measure: Proportion of responding patients
timeFrame: Endpoint
measure: Change from baseline Mean Pain Interference with Sleep Score
timeFrame: Weekly and Endpoint
measure: Change from baseline in the 5 sub-scores of the McGill Reduced Pain Questionnaire: the sensory score, the affective score, the total score for pain descriptors, a visual analogue scale, and a scale of Present Pain Intensity
timeFrame: Endpoint
measure: Global Change Impression from the Patient's Point of View
timeFrame: Endpoint
measure: Change from baseline in quality of life
timeFrame: Endpoint
measure: Global Change Impression from the Physician's Point of View
timeFrame: Endpoint
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Pfizer Investigational Site
state: Ceara
city: Taguatinga
country: Brazil
facility: Pfizer Investigational Site
state: DF
city: Belo Horizonte
country: Brazil
facility: Pfizer Investigational Site
state: MG
city: Curitiba
country: Brazil
facility: Pfizer Investigational Site
state: Parana
city: Recife
country: Brazil
facility: Pfizer Investigational Site
state: Pernambuco
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: