Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

Diabetic Neuropathies Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00507936
• Other study ID #: M06-850
• Secondary ID: 2007-001139-71
• Status: Completed
• Phase: Phase 2
• First received: July 25, 2007
• Last updated: January 15, 2013
• Start date: August 2007
• Est. completion date: October 2008

Study information

• Verified date: January 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuralgia
• Diabetic Neuropathies
• Diabetic Neuropathy, Painful
• Diabetic Polyneuropathy
• Neuralgia
• Neuralgia, Diabetic
• Polyneuropathies

Intervention

Drug:
• ABT-894
ABT-894 1 mg capsule BID throughout treatment period
• ABT-894
ABT-894 2 mg capsule BID throughout treatment period
• ABT-894
ABT-894 4 mg capsule BID throughout treatment period
• placebo
placebo capsule BID throughout the treatment period
• Duloxetine
Duloxetine 60 mg QD throughout treatment period

Locations

Country	Name	City	State
Canada	Site Reference ID/Investigator# 8508	Kingston
Canada	Site Reference ID/Investigator# 8436	Laval
Canada	Site Reference ID/Investigator# 8481	Winnipeg
France	Site Reference ID/Investigator# 5258	Corbeil Essonnes
France	Site Reference ID/Investigator# 7696	Nanterre
France	Site Reference ID/Investigator# 5260	Narbonne
France	Site Reference ID/Investigator# 5171	Nevers
France	Site Reference ID/Investigator# 7115	Nimes
Germany	Site Reference ID/Investigator# 6763	Berlin
Germany	Site Reference ID/Investigator# 7117	Essen
Germany	Site Reference ID/Investigator# 5034	Frankfurt
Germany	Site Reference ID/Investigator# 6760	Heidelberg
Germany	Site Reference ID/Investigator# 6732	Mainz
Italy	Site Reference ID/Investigator# 5018	Milan
Italy	Site Reference ID/Investigator# 5006	Rome
Mexico	Site Reference ID/Investigator# 8427	Guadalajara
Mexico	Site Reference ID/Investigator# 8497	Mexico D.F.
Mexico	Site Reference ID/Investigator# 8125	Monterrey, N.L.
Puerto Rico	Site Reference ID/Investigator# 8120	Ponce
Puerto Rico	Site Reference ID/Investigator# 8121	San Juan
United States	Site Reference ID/Investigator# 6052	Anaheim	California
United States	Site Reference ID/Investigator# 5277	Brockton	Massachusetts
United States	Site Reference ID/Investigator# 5947	Cincinnati	Ohio
United States	Site Reference ID/Investigator# 5276	Clearwater	Florida
United States	Site Reference ID/Investigator# 6869	Cuyahoga Falls	Ohio
United States	Site Reference ID/Investigator# 7064	Garden Grove	California
United States	Site Reference ID/Investigator# 6781	Hialeah	Florida
United States	Site Reference ID/Investigator# 7699	Houston	Texas
United States	Site Reference ID/Investigator# 5206	Little Rock	Arkansas
United States	Site Reference ID/Investigator# 5207	Mesa	Arizona
United States	Site Reference ID/Investigator# 8286	National City	California
United States	Site Reference ID/Investigator# 5216	New York	New York
United States	Site Reference ID/Investigator# 5946	New York	New York
United States	Site Reference ID/Investigator# 6045	New York	New York
United States	Site Reference ID/Investigator# 7483	New York	New York
United States	Site Reference ID/Investigator# 7387	North Little Rock	Arkansas
United States	Site Reference ID/Investigator# 7906	Omaha	Nebraska
United States	Site Reference ID/Investigator# 7514	Palm Beach Gardens	Florida
United States	Site Reference ID/Investigator# 6047	Pasadena	Maryland
United States	Site Reference ID/Investigator# 6053	Phoenix	Arizona
United States	Site Reference ID/Investigator# 5217	Portland	Oregon
United States	Site Reference ID/Investigator# 5836	San Antonio	Texas
United States	Site Reference ID/Investigator# 5899	San Antonio	Texas
United States	Site Reference ID/Investigator# 5950	San Antonio	Texas
United States	Site Reference ID/Investigator# 7187	San Antonio	Texas
United States	Site Reference ID/Investigator# 6054	Seattle	Washington
United States	Site Reference ID/Investigator# 6043	St. Louis	Missouri
United States	Site Reference ID/Investigator# 6044	St. Louis	Missouri
United States	Site Reference ID/Investigator# 8113	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Italy,  Mexico,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of each ABT-894 dose (1 mg, 2 mg, or 4 mg BID) versus placebo in the treatment of pain due to DNP		Change from baseline to final 24-hour average pain score	No
Secondary	Proportions of treatment responders; subjects who complete treatment period with 30% improvement		From Baseline to final 24-hour average pain score	No
Secondary	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		Weekly through treatment phase	No
Secondary	Brief Pain Inventory (BPI) (short form) including Pain Severity		At each visit from Baseline to Week 8 visit	No
Secondary	Clinician Global Impression: Severity (CGI-S) and Patient Global Impression: Change (PGI-C)		At each visit from Baseline to Week 8 visit	No