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Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain | Clinical Trials | Clareo Health

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Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

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

NCT00507936•AbbVie (prior sponsor, Abbott)

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.
+6 more criteria

Locations (49)

Site Reference ID/Investigator# 5207

Mesa, Arizona, United States

Site Reference ID/Investigator# 6053

Phoenix, Arizona, United States

Site Reference ID/Investigator# 5206

Little Rock, Arkansas, United States

Site Reference ID/Investigator# 7387

North Little Rock, Arkansas, United States

Site Reference ID/Investigator# 6052

Anaheim, California, United States

Site Reference ID/Investigator# 7064

Garden Grove, California, United States

Site Reference ID/Investigator# 8286

National City, California, United States

Site Reference ID/Investigator# 5276

Clearwater, Florida, United States

Site Reference ID/Investigator# 6781

Hialeah, Florida, United States

Site Reference ID/Investigator# 7514

Palm Beach Gardens, Florida, United States

Key Dates

Start Date

August 1, 2007

Primary Completion Date

October 1, 2008

Completion Date

October 1, 2008

Last Updated

January 23, 2013

Enrollment

280

ACTUAL participants

Conditions

Diabetic NeuralgiaDiabetic NeuropathiesDiabetic Neuropathy, PainfulDiabetic PolyneuropathyNeuralgia, Diabetic

Interventions

ABT-894

DRUG

ABT-894

DRUG

ABT-894

DRUG

placebo

DRUG

Duloxetine

DRUG

Integrated Oral Care Intervention for Xerostomia in Diabetes Patients

NCT07425275

Diabetes MellitusDiabetic Neuropathies

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RECRUITING

Cross-cultural Adaptation and Validity of the Arabic-translated NEUROPATHY-SPECIFIC QUALITY OF LIFE Questionnaire

NCT06483620

Diabetic NeuropathiesDiabetic Peripheral Neuropathy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

Inclusion Criteria

Exclusion Criteria

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