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

NCT00837941 | Withdrawn Phase 2

• 2 other identifiers: 0000-1152009_515
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Painful Diabetic Neuropathy

Outcome Measures

Primary Outcomes (1)

• analgesic efficacy measured by patients self reported pain level after single dose administration

  5-11 hours after single dose is administered

Secondary Outcomes (1)

• The onset of analgesic efficacy following single dose of pregabalin and duloxetine hydrochloride versus placebo

  24 hours after single dose is administered

Study Arms (6)

1

EXPERIMENTAL

sequence 1 - Pregabalin, Duloxetine hydrochloride, Diphenhydramine hydrochloride

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

2

EXPERIMENTAL

sequence 2 - Duloxetine hydrochloride, Pregabalin, Diphenhydramine hydrochloride

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

3

EXPERIMENTAL

sequence 3 - Diphenhydramine hydrochloride, Duloxetine hydrochloride, Pregabalin

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

4

EXPERIMENTAL

sequence 4 - Pregabalin, Diphenhydramine hydrochloride, Duloxetine hydrochloride

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

5

EXPERIMENTAL

sequence 5 - Duloxetine hydrochloride, Diphenhydramine hydrochloride, Pregabalin

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

6

EXPERIMENTAL

sequence 6 - Diphenhydramine hydrochloride, Pregabalin, Duloxetine hydrochloride

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

Interventions

Comparator: A: Pregabalin DRUG

1 Pregabalin 300 mg capsule

1; 2; 3; 4; 5; 6

Comparator: B: Duloxetine DRUG

1 Duloxetine hydrochloride 60 mg capsule

1; 2; 3; 4; 5; 6

Comparator: C: Diphenhydramine hydrochloride DRUG

1 Diphenhydramine hydrochloride 25mg capsule

1; 2; 3; 4; 5; 6

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2009
• First Posted: February 6, 2009
• Study Start: April 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: September 1, 2009
• Last Updated: July 27, 2015

Record last verified: 2015-07