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

Painful Diabetic Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00837941
• Other study ID #: 0000-115
• Secondary ID: 2009_515
• Status: Withdrawn
• Phase: Phase 2
• First received: February 5, 2009
• Last updated: July 24, 2015
• Start date: April 2009
• Est. completion date: September 2009

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Pain
• Painful Diabetic Neuropathy

Intervention

Drug:
• Comparator: A: Pregabalin
1 Pregabalin 300 mg capsule
• Comparator: B: Duloxetine
1 Duloxetine hydrochloride 60 mg capsule
• Comparator: C: Diphenhydramine hydrochloride
1 Diphenhydramine hydrochloride 25mg capsule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	analgesic efficacy measured by patients self reported pain level after single dose administration		5-11 hours after single dose is administered	No
Secondary	The onset of analgesic efficacy following single dose of pregabalin and duloxetine hydrochloride versus placebo		24 hours after single dose is administered	No