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Evaluation of the Impact of Training on Outcome Measures in Subjects With Painful Diabetic Neuropathy

NCT01770964 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2013-01-18

No results posted yet for this study

Summary

The difference between active treatment and placebo in a clinical trial of an analgesic appears to depend on a variety of factors other than the actual efficacy of the drug itself, including various aspects of study design and conduct. One potential such factor is how information about the study is presented to research staff and patients. The purpose of this study is to examine the impact of different presentations of information on the difference between pregabalin and placebo observed in a clinical trial in patients with painful diabetic neuropathy.

Conditions

Interventions

DRUG

Pregabalin

DRUG

placebo

BEHAVIORAL

Training Type A

BEHAVIORAL

Training Type B

Sponsors & Collaborators

  • Astellas Pharma Europe B.V.

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • Analgesic Solutions

    lead INDUSTRY

Principal Investigators

  • Jeremiah J Trudeau, PhD · Analgesic Solutions

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01770964 on ClinicalTrials.gov