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

Merck Sharp & Dohme (MSD) logo

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Withdrawn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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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