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.

Study Overview

• Status: Withdrawn
• Conditions: Painful Diabetic Neuropathy
• Intervention / Treatment: Drug: Comparator: A: Pregabalin; Drug: Comparator: B: Duloxetine; Drug: Comparator: C: Diphenhydramine hydrochloride

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; sequence 1 - Pregabalin, Duloxetine hydrochloride, Diphenhydramine hydrochloride	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: 2; sequence 2 - Duloxetine hydrochloride, Pregabalin, Diphenhydramine hydrochloride	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: 3; sequence 3 - Diphenhydramine hydrochloride, Duloxetine hydrochloride, Pregabalin	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: 4; sequence 4 - Pregabalin, Diphenhydramine hydrochloride, Duloxetine hydrochloride	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: 5; sequence 5 - Duloxetine hydrochloride, Diphenhydramine hydrochloride, Pregabalin	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: 6; sequence 6 - Diphenhydramine hydrochloride, Pregabalin, Duloxetine hydrochloride	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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Anticipated): August 1, 2009
• Study Completion (Anticipated): September 1, 2009

Study Registration Dates

• First Submitted: February 5, 2009
• First Submitted That Met QC Criteria: February 5, 2009
• First Posted (Estimate): February 6, 2009

Study Record Updates

• Last Update Posted (Estimate): July 27, 2015
• Last Update Submitted That Met QC Criteria: July 24, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pain; Diabetic Neuropathies; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Tranquilizing Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Hypnotics and Sedatives; Anti-Anxiety Agents; Anticonvulsants; Serotonin and Noradrenaline Reuptake Inhibitors; Anesthetics, Local; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Anti-Allergic Agents; Sleep Aids, Pharmaceutical; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Duloxetine Hydrochloride; Diphenhydramine; Promethazine; Pregabalin
• Other Study ID Numbers: 0000-115; 2009_515