Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain - Full Text View

Purpose

This study will compare the efficacy and the safety of ABT-894 (1mg, 2mg or 4mg capsules) administered BID to placebo in the treatment of DNP. Another treatment arm will be Duloxetine 60mg administered once daily (QD). Approximately 275 subjects will be enrolled into the study at approximately 50 sites in both the United States and Europe. The study will be divided into the following periods: Screening/Washout (21 days) followed by a Baseline Visit, an 8-week Treatment Period and a 1-week Follow-up Visit.

Condition	Intervention	Phase
Diabetic Neuralgia Diabetic Neuropathies Diabetic Neuropathy, Painful Diabetic Polyneuropathy Neuralgia, Diabetic	Drug: ABT-894 Drug: placebo Drug: Duloxetine	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Global, Multicenter, Randomized, Double-Blind Placebo Controlled Study Comparing the Safety and Efficacy of ABT-894, Duloxetine and Placebo in Subjects With Diabetic Neuropathic Pain

Resource links provided by NLM:

Genetics Home Reference related topics: Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Diabetic Nerve Problems

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:

Efficacy of each ABT-894 dose (1 mg, 2 mg, or 4 mg BID) versus placebo in the treatment of pain due to DNP [ Time Frame: Change from baseline to final 24-hour average pain score ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportions of treatment responders; subjects who complete treatment period with 30% improvement [ Time Frame: From Baseline to final 24-hour average pain score ] [ Designated as safety issue: No ]
Mean of 24-hour worst pain severity, average of night pain, and average of morning pain measured by the 11-point Likert scale and from subject's daily diary [ Time Frame: Weekly through treatment phase ] [ Designated as safety issue: No ]
Brief Pain Inventory (BPI) (short form) including Pain Severity [ Time Frame: At each visit from Baseline to Week 8 visit ] [ Designated as safety issue: No ]
Clinician Global Impression: Severity (CGI-S) and Patient Global Impression: Change (PGI-C) [ Time Frame: At each visit from Baseline to Week 8 visit ] [ Designated as safety issue: No ]

Enrollment:	280
Study Start Date:	August 2007
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A ABT-894 1 mg BID	Drug: ABT-894 ABT-894 1 mg capsule BID throughout treatment period
Experimental: B ABT-894 2 mg BID	Drug: ABT-894 ABT-894 2 mg capsule BID throughout treatment period
Experimental: C ABT-894 4 mg BID	Drug: ABT-894 ABT-894 4 mg capsule BID throughout treatment period
Placebo Comparator: D	Drug: placebo placebo capsule BID throughout the treatment period
Active Comparator: E Duloxetine 60 mg QD	Drug: Duloxetine Duloxetine 60 mg QD throughout treatment period

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

If female, subject is either postmenopausal for at least two (2) years or surgically sterile or is practicing at least one (1) method of birth control.
If female, subject must have negative results for pregnancy tests.
The subject must have a diagnosis of diabetes mellitus (Type 1 or Type 2) and a diagnosis of DNP.
Subject's DNP must be present for a minimum of six (6) months and should have begun in the feet with relative symmetrical onset.
Subject has an HgbA1c <= 9. Subjects who have an HgbA1c > 9 and <= 11 may be included in the study.
If male, the subject is surgically sterile (vasectomy), is sexually inactive, or is using a barrier method (condom) of birth control for the duration of the study and for 7 days following the last dose of study drug.

Exclusion Criteria:

The subject has failed previous treatment with duloxetine for DNP.
Subject has a diagnosis of narrow-angle glaucoma.
Subject has a history of an allergic reaction or intolerance to duloxetine, acetaminophen, or any other NNR agonist.
Subject has a diagnosis of fibromyalgia that requires treatment.
Subject has a functioning implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain.
Subject has a history of seizures (febrile may be ok) or major depressive episode within the past two (2) years or major psychiatric disorder including bipolar disorder, schizophrenia or borderline personality disorder.
Subject has a history of myocardial infarction (MI) within six (6) months of the Screening Visit.
Subject has unstable angina.
Subject has ventricular arrhythmia requiring anti-arrhythmic therapy.
Subject has undergone a cardiac revascularization procedure within 30 days of Screening.
Subject has uncontrolled hypertension (HTN) defined as a systolic blood pressure (BP) >= 160 and/or a diastolic blood pressure (BP) >= 100 at Screening and/or Baseline.
Subject has a clinically significant abnormal ECG at Screening
Subject has an active malignancy of any type or has been diagnosed with or treated for cancer within the past 5 years.
Subject has a positive result for drugs of abuse at Screening with the exception of a positive result for a known prescribed medication.
Subject's screening laboratory results show hepatitis A, B or C.
Subject has a known or suspected history of Human Immunodeficiency Virus (HIV).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507936

Show 49 Study Locations

Sponsors and Collaborators

AbbVie (prior sponsor, Abbott)

Investigators

Study Director:

Wolfram Nothaft, MD

AbbVie

More Information

No publications provided

Responsible Party:	AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:	NCT00507936 History of Changes
Other Study ID Numbers:	M06-850, 2007-001139-71
Study First Received:	July 25, 2007
Last Updated:	January 15, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by AbbVie:

Diabetic Neuropathy
Painful
Diabetic Polyneuropathy
Neuralgia

Diabetic
Diabetic Neuropathies
Diabetic Neuralgia

Additional relevant MeSH terms:

Diabetic Neuropathies
Neuralgia
Pain
Polyneuropathies
Demyelinating Diseases
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
Duloxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on May 22, 2013