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

Merck Sharp & Dohme (MSD)

Status and phase: Withdrawn; Phase 2

Conditions: Painful Diabetic Neuropathy

Treatments: Drug: Comparator: C: Diphenhydramine hydrochloride; Drug: Comparator: A: Pregabalin; Drug: Comparator: B: Duloxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00837941

0000-115

2009_515

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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0 participants in 6 patient groups

1

Experimental group

Description:

sequence 1 - Pregabalin, Duloxetine hydrochloride, Diphenhydramine hydrochloride

Treatment:

Drug: Comparator: B: Duloxetine

Drug: Comparator: C: Diphenhydramine hydrochloride

Drug: Comparator: A: Pregabalin

2

Experimental group

Description:

sequence 2 - Duloxetine hydrochloride, Pregabalin, Diphenhydramine hydrochloride

Treatment:

Drug: Comparator: B: Duloxetine

Drug: Comparator: C: Diphenhydramine hydrochloride

Drug: Comparator: A: Pregabalin

3

Experimental group

Description:

sequence 3 - Diphenhydramine hydrochloride, Duloxetine hydrochloride, Pregabalin

Treatment:

Drug: Comparator: B: Duloxetine

Drug: Comparator: C: Diphenhydramine hydrochloride

Drug: Comparator: A: Pregabalin

4

Experimental group

Description:

sequence 4 - Pregabalin, Diphenhydramine hydrochloride, Duloxetine hydrochloride

Treatment:

Drug: Comparator: B: Duloxetine

Drug: Comparator: C: Diphenhydramine hydrochloride

Drug: Comparator: A: Pregabalin

5

Experimental group

Description:

sequence 5 - Duloxetine hydrochloride, Diphenhydramine hydrochloride, Pregabalin

Treatment:

Drug: Comparator: B: Duloxetine

Drug: Comparator: C: Diphenhydramine hydrochloride

Drug: Comparator: A: Pregabalin

6

Experimental group

Description:

sequence 6 - Diphenhydramine hydrochloride, Pregabalin, Duloxetine hydrochloride

Treatment:

Drug: Comparator: B: Duloxetine

Drug: Comparator: C: Diphenhydramine hydrochloride

Drug: Comparator: A: Pregabalin