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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Painful Diabetic Neuropathy

Intervention: Comparator: A: Pregabalin (Drug); Comparator: B: Duloxetine (Drug); Comparator: C: Diphenhydramine hydrochloride (Drug)

Phase: Phase 2

Status: Withdrawn

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.


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.

Clinical Details

Official title: Qualification of Single Dose Administration of Analgesic Therapy in the Treatment of Chronic Neuropathic Pain in Patients With Painful Diabetic Neuropathy

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: analgesic efficacy measured by patients self reported pain level after single dose administration

Secondary outcome: The onset of analgesic efficacy following single dose of pregabalin and duloxetine hydrochloride versus placebo


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


Inclusion Criteria:

- Patient has been treated for type 1 or 2 diabetes mellitus with glycosylated


- Patient has pain in both feet that occurred after onset of diabetes

- Patient agrees to maintain a consistent activity level throughout the study

- Patient is not on chronic pain therapy, or is on a stable dose of one pain therapy

- Female patients of reproductive potential must agree to use two acceptable methods of

birth control through out the study

- Patients taking a pain medication must be on a stable dose at least 1 month prior to

participating in study Exclusion Criteria:

- Patient has a history of congestive heart failure

- Patient has/had a seizure disorder

- Patient has tried and failed 3 or more drugs to treat neuropathic pain

- Patient is currently taking pregabalin or duloxetine hydrochloride

- Patient has had a malignancy within the past 2 years (excluding basal cell carcinoma)

- Patient has history of hepatitis B or C or HIV infection

- Patient has skin-condition that may decrease sensitivity in area of neuropathic pain

Locations and Contacts

Additional Information

Starting date: April 2009
Last updated: July 24, 2015

Page last updated: August 23, 2015

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