A Study of Single Dose Pain Therapy in Patients With Painful Diabetic Neuropathy (0000-115)

NCT00837941 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-07-27

No results posted yet for this study

Summary

The purpose of this study is to determine if analgesic efficacy can be detected with single dose administration in patients with chronic neuropathic pain due to painful diabetic neuropathy.

Conditions

  • Painful Diabetic Neuropathy

Interventions

DRUG

Comparator: A: Pregabalin

1 Pregabalin 300 mg capsule

DRUG

Comparator: B: Duloxetine

1 Duloxetine hydrochloride 60 mg capsule

DRUG

Comparator: C: Diphenhydramine hydrochloride

1 Diphenhydramine hydrochloride 25mg capsule

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-08-31
Completion
2009-09-30

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Entities

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 NCT00837941 on ClinicalTrials.gov