A Study of Single Dose Pain Therapy in Patients With Painful Diabetic Neuropathy (0000-115)(WITHDRAWN) - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00837941

Purpose

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.

Condition	Intervention	Phase
Painful Diabetic Neuropathy	Drug: Comparator: A: Pregabalin Drug: Comparator: B: Duloxetine Drug: Comparator: C: Diphenhydramine hydrochloride	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Qualification of Single Dose Administration of Analgesic Therapy in the Treatment of Chronic Neuropathic Pain in Patients With Painful Diabetic Neuropathy

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Diabetic Nerve Problems

Drug Information available for: Promethazine hydrochloride Diphenhydramine Promethazine Diphenhydramine citrate Duloxetine Duloxetine hydrochloride Pregabalin Diphenhydramine hydrochloride

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	30
Study Start Date:	April 2009
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837941

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00837941 History of Changes
Other Study ID Numbers:	2009_515, 115
Study First Received:	February 5, 2009
Last Updated:	July 30, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Diabetic Neuropathies
Pain
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Poisoning

Substance-Related Disorders
Diphenhydramine
Promethazine
Duloxetine
Pregabalin
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists

ClinicalTrials.gov processed this record on February 09, 2012