NCT00141401

Brief Summary

To evaluate long-term efficacy and safety of pregabalin in patients with diabetic peripheral neuropathy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 1999

Longer than P75 for phase_3

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

September 1, 1999

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
Last Updated

August 17, 2007

Status Verified

August 1, 2007

First QC Date

August 30, 2005

Last Update Submit

August 15, 2007

Conditions

Diabetic Neuropathy, Painful

Outcome Measures

Primary Outcomes (1)

  • Safety Efficacy

Interventions

PregabalinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must have received pregabalin or amitriptyline or placebo under double-blind conditions under double-blind conditions at least during first 3 weeks if double-blind treatment phase of preceding study.

You may not qualify if:

  • Patients cannot be included if they experienced a serious adverse event while participating in preceding double-blind study, which was determined to be related to the study medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

September 1, 1999

Study Completion

July 1, 2005

Last Updated

August 17, 2007

Record last verified: 2007-08