NCT00644748

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2003

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2008

Completed
Last Updated

February 2, 2021

Status Verified

October 1, 2008

First QC Date

March 25, 2008

Last Update Submit

February 1, 2021

Conditions

Diabetic Neuropathies

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Mean Pain Score

    Endpoint

Secondary Outcomes (7)

  • Change from baseline Mean Pain Score

    Weekly

  • Proportion of responding patients

    Endpoint

  • Change from baseline Mean Pain Interference with Sleep Score

    Weekly and Endpoint

  • 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

    Endpoint

  • Global Change Impression from the Patient's Point of View

    Endpoint

  • +2 more secondary outcomes

Study Arms (1)

Gabapentin group

EXPERIMENTAL
Drug: gabapentin

Interventions

gabapentinDRUG

Gabapentin oral capsules: Week 0: Day 1: 300 mg; Day 2: 600 mg (2 doses of 300 mg); Day 3: 900 mg (3 doses of 300 mg), maintained until the end of the week; After this point, the total daily dose was divided in 3 equal doses. Week 1: Day 1: 1200 mg; Day 2 to 7: 1800 mg Week 2: Day 1: 2100 mg; Day 2 to 7: 2400 mg Week 3: Day 1: 2700 mg; Day 2 to 7: 3600 mg Weeks 4 to 11: 3600 mg

Gabapentin group

Eligibility Criteria

Age51 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Pfizer Investigational Site

Fortaleza, Ceará, 60120-021, Brazil

Location

Pfizer Investigational Site

Taguatinga, Federal District, 72119-900, Brazil

Location

Pfizer Investigational Site

Belo Horizonte, Minas Gerais, 30150-221, Brazil

Location

Pfizer Investigational Site

Curitiba, Paraná, 80060-150, Brazil

Location

Pfizer Investigational Site

Recife, Pernambuco, 52051-380, Brazil

Location

Pfizer Investigational Site

Rio de Janeiro, Rio de Janeiro, 20211-340, Brazil

Location

Pfizer Investigational Site

Porto Alegre, Rio Grande do Sul, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 01246-903, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 04020-041, Brazil

Location

Pfizer Investigational Site

Location

Related Links

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2008

First Posted

March 27, 2008

Study Start

May 1, 2003

Study Completion

August 1, 2004

Last Updated

February 2, 2021

Record last verified: 2008-10

Locations

BR(9)