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

Study Overview
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Brief Summary
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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.

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

Conditions
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Painful Diabetic Neuropathy

Intervention / Treatment
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* Drug: Comparator: A: Pregabalin
* Drug: Comparator: B: Duloxetine
* Drug: Comparator: C: Diphenhydramine hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>sequence 1 - Pregabalin, Duloxetine hydrochloride, Diphenhydramine hydrochloride | Drug: Comparator: A: Pregabalin<br>* 1 Pregabalin 300 mg capsule<br>Drug: Comparator: B: Duloxetine<br>* 1 Duloxetine hydrochloride 60 mg capsule<br>Drug: Comparator: C: Diphenhydramine hydrochloride<br>* 1 Diphenhydramine hydrochloride 25mg capsule<br>|
| Experimental: 2<br>sequence 2 - Duloxetine hydrochloride, Pregabalin, Diphenhydramine hydrochloride | Drug: Comparator: A: Pregabalin<br>* 1 Pregabalin 300 mg capsule<br>Drug: Comparator: B: Duloxetine<br>* 1 Duloxetine hydrochloride 60 mg capsule<br>Drug: Comparator: C: Diphenhydramine hydrochloride<br>* 1 Diphenhydramine hydrochloride 25mg capsule<br>|
| Experimental: 3<br>sequence 3 - Diphenhydramine hydrochloride, Duloxetine hydrochloride, Pregabalin | Drug: Comparator: A: Pregabalin<br>* 1 Pregabalin 300 mg capsule<br>Drug: Comparator: B: Duloxetine<br>* 1 Duloxetine hydrochloride 60 mg capsule<br>Drug: Comparator: C: Diphenhydramine hydrochloride<br>* 1 Diphenhydramine hydrochloride 25mg capsule<br>|
| Experimental: 4<br>sequence 4 - Pregabalin, Diphenhydramine hydrochloride, Duloxetine hydrochloride | Drug: Comparator: A: Pregabalin<br>* 1 Pregabalin 300 mg capsule<br>Drug: Comparator: B: Duloxetine<br>* 1 Duloxetine hydrochloride 60 mg capsule<br>Drug: Comparator: C: Diphenhydramine hydrochloride<br>* 1 Diphenhydramine hydrochloride 25mg capsule<br>|
| Experimental: 5<br>sequence 5 - Duloxetine hydrochloride, Diphenhydramine hydrochloride, Pregabalin | Drug: Comparator: A: Pregabalin<br>* 1 Pregabalin 300 mg capsule<br>Drug: Comparator: B: Duloxetine<br>* 1 Duloxetine hydrochloride 60 mg capsule<br>Drug: Comparator: C: Diphenhydramine hydrochloride<br>* 1 Diphenhydramine hydrochloride 25mg capsule<br>|
| Experimental: 6<br>sequence 6 - Diphenhydramine hydrochloride, Pregabalin, Duloxetine hydrochloride | Drug: Comparator: A: Pregabalin<br>* 1 Pregabalin 300 mg capsule<br>Drug: Comparator: B: Duloxetine<br>* 1 Duloxetine hydrochloride 60 mg capsule<br>Drug: Comparator: C: Diphenhydramine hydrochloride<br>* 1 Diphenhydramine hydrochloride 25mg capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesic efficacy measured by patients self reported pain level after single dose administration |  | 5-11 hours after single dose is administered | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The onset of analgesic efficacy following single dose of pregabalin and duloxetine hydrochloride versus placebo |  | 24 hours after single dose is administered |