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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00837941
First received: February 5, 2009
Last updated: August 8, 2014
Last verified: August 2014

February 5, 2009
August 8, 2014
April 2009
August 2009   (final data collection date for primary outcome measure)
analgesic efficacy measured by patients self reported pain level after single dose administration [ Time Frame: 5-11 hours after single dose is administered ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00837941 on ClinicalTrials.gov Archive Site
The onset of analgesic efficacy following single dose of pregabalin and duloxetine hydrochloride versus placebo [ Time Frame: 24 hours after single dose is administered ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Single Dose Pain Therapy in Patients With Painful Diabetic Neuropathy (0000-115)
Qualification of Single Dose Administration of Analgesic Therapy in the Treatment of Chronic Neuropathic Pain in Patients With Painful Diabetic Neuropathy

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Painful Diabetic Neuropathy
  • 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
  • Experimental: 1
    sequence 1 - Pregabalin, Duloxetine hydrochloride, Diphenhydramine hydrochloride
    Interventions:
    • Drug: Comparator: A: Pregabalin
    • Drug: Comparator: B: Duloxetine
    • Drug: Comparator: C: Diphenhydramine hydrochloride
  • Experimental: 2
    sequence 2 - Duloxetine hydrochloride, Pregabalin, Diphenhydramine hydrochloride
    Interventions:
    • Drug: Comparator: A: Pregabalin
    • Drug: Comparator: B: Duloxetine
    • Drug: Comparator: C: Diphenhydramine hydrochloride
  • Experimental: 3
    sequence 3 - Diphenhydramine hydrochloride, Duloxetine hydrochloride, Pregabalin
    Interventions:
    • Drug: Comparator: A: Pregabalin
    • Drug: Comparator: B: Duloxetine
    • Drug: Comparator: C: Diphenhydramine hydrochloride
  • Experimental: 4
    sequence 4 - Pregabalin, Diphenhydramine hydrochloride, Duloxetine hydrochloride
    Interventions:
    • Drug: Comparator: A: Pregabalin
    • Drug: Comparator: B: Duloxetine
    • Drug: Comparator: C: Diphenhydramine hydrochloride
  • Experimental: 5
    sequence 5 - Duloxetine hydrochloride, Diphenhydramine hydrochloride, Pregabalin
    Interventions:
    • Drug: Comparator: A: Pregabalin
    • Drug: Comparator: B: Duloxetine
    • Drug: Comparator: C: Diphenhydramine hydrochloride
  • Experimental: 6
    sequence 6 - Diphenhydramine hydrochloride, Pregabalin, Duloxetine hydrochloride
    Interventions:
    • Drug: Comparator: A: Pregabalin
    • Drug: Comparator: B: Duloxetine
    • Drug: Comparator: C: Diphenhydramine hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00837941
0000-115, 2009_515
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP