A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of ABT-894 versus Placebo in Subjects with Diabetic Neuropathic Pai

Conditions: diabetic neuropathic pain
MedDRA version: 9.1Level: LLTClassification code 10054095Term: Neuropathic pain

Registration Number: EUCTR2007-001140-47-DE

Lead Sponsor: Abbott GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 110

Inclusion Criteria

1. Subject must voluntarily sign and date an informed consent form, approved by an
Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to
the conduct of any study-specific procedures.
2. Subject is male or female between 18 and 75 years of age (inclusive) at the
Screening Visit.
3. The subject must have a score of 3 or greater on the physical assessment portion of
the Michigan Neuropathic Screening Instrument at the Screening Visit.
4. At the Baseline Visit the subject must meet the following criteria:
? An average score of 4 or greater on the 24-hour average pain score (11-Point
Likert Scale) collected for approximately 7 days prior to the Baseline Visit,
and
? A compliance rating of no less than 60% on the 24-hour average pain score
(11 Point Likert Scale) collected over approximately 7 days prior to the
Baseline Visit.
5. Subject must have an average of 4 or greater on the BPI average of pain score at
the Baseline Visit.
6. Subjects must be able to adhere to the study visit schedule and all other protocol
requirements, including the completion of daily pain diaries.
7. If female, subject is either not of childbearing potential (defined as
postmenopausal for at least two (2) years or surgically sterile [bilateral tubal
ligation, bilateral oophorectomy or hysterectomy]) or subject is of childbearing
potential and practicing at least one (1) of the following methods of birth control:
? Total abstinence from sexual intercourse is only accepted as a form of effective contraception when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable method of contraception.)
? A vasectomized partner
? Contraceptives (oral, parenteral or transdermal) for 3 consecutive months
prior to study drug administration, or use of an intrauterine device
? Other acceptable methods (condoms, sponge, diaphragm or vaginal ring with spermicidal jellies or creams) for a minimum of 1 complete menstrual cycle.
8. If female, subject must have negative results for pregnancy tests performed:
? On serum sample obtained at the Screening Visit within 21 days prior to
initial study drug administration, and
? Prior to dosing on a urine sample.
9. The subject must have a diagnosis of diabetes mellitus (Type 1 or Type 2) and a
diagnosis of painful distal symmetric diabetic polyneuropathy.
10. Subject's distal symmetric diabetic polyneuropathy must be present for a minimum
of six (6) months and should have begun in the feet with relative symmetrical
onset.
11. Subject has an HgbA1c result = 11.
12. Subject must be willing to washout of all analgesics (except stable doses of
NSAIDs for conditions other than DNP) for at least 5 half-lives of the longest
acting analgesic or 2 days whichever is longer and be willing to remain off of
medication during the 7 days prior to the Baseline Visit.
13. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subject has a history of an allergic reaction or clinically significant sensitivity or intolerance to acetaminophen or a NNR agonist.
2. Subject has a medical condition or illness, which is not well controlled that would, in the opinion of the Investigator, preclude study participation or interfere with the
assessment of pain and other symptoms of DNP.
3. Subject has a symptomatic diagnosis of fibromyalgia that requires treatment.
4. Subject is currently receiving analgesics for conditions other than DNP, except for
stable doses of NSAIDs for a non-neuropathic pain condition (e.g. Osteoarthritis).
5. Subject has a clinically symptomatic neuropathic pain condition other than DNP.
6. Subject requires treatment with a NSAID for a non-neuropathic pain condition (e.g., non-elective or COX-2 inhibitors) at a dose that has not been stable for at least 30 days. If the subject is on a stable dose of NSAIDs (> 30 days), inclusion into the study is permitted.
7. Subject has a functioning implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain.
8. Subject has a history of:
? Seizures, including those requiring treatment with anticonvulsant. Febrile seizures will be permitted at the discretion of the Investigator.
? Major depressive episode within the past two (2) years (as defined by DSMV IV).
? Major psychiatric disorder including bipolar disorder, schizophrenia or borderline personality disorder.
? Other psychiatric disorders as determined by the Investigator.
9. Subject has a history of myocardial infarction (MI).
10. Subject has unstable angina.
11. Subject has ventricular arrhythmia requiring anti-arrhythmic therapy.
12. Subject has undergone a cardiac revascularization procedure.
13. Subject has New York Heart Association (NYHA) functional heart failure classification of Class III or greater.
14. Has stable angina and has had their anti-anginal medication changed or altered
within the last 3 months.
15. Uncontrolled hypertension (HTN) defined as a systolic BP =150 and/or a diastolic
blood pressure = 100 at two consecutive visits (Screening and Baseline).
16. Subject has a clinically significant abnormal ECG or (QTc) of > 450 ms at Screening.
17. Subject has any clinically significant infection/injury/illness within thirty (30) days prior to the Screening Visit.
18. Subject has a newly diagnosed clinically significant medical condition that requires therapeutic intervention (within thirty (30) days prior to the Screening
Visit) or unstable medical condition that significantly impacts health.
19. Subject has an active malignancy of any type or has been diagnosed with or treated for cancer within the past 5 years. Subjects with basal cell carcinoma of the skin that has been successfully treated will be allowed to participate.
20. Subject has an active substance abuse or history of chronic substance abuse within the past year, or prior chronic substance abuse judged likely, by the Investigator, to recur during the study period.
21. Subject has a positive result for drugs of abuse at Screening with the exception of a positive result for a known prescribed medication.
22. Subject is consuming more than 4 alcoholic drinks per day.
23. Subject's screening laboratory results show the presence of Hepatitis B surface
antigen (HBs Ag), Hepatitis C antibody (HCV Ab), or active Hepatitis A immunoglobulin M antibody (HAV IgM Ab).
24. Subject has a known or suspected history

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the analgesic efficacy and the safety of ABT-894 (6 mg tablets) administered twice daily (BID) to placebo in the treatment of diabetic neuropathic pain (DNP).;Secondary Objective: To explore the pharmacokinetic and pharmacogenetic characteristics of ABT-894 in the DNP population.;Primary end point(s): The weekly mean of 24-hour average pain score measured by the 11-point Likert Scale and calculated from subject's daily diary.

Secondary Outcome Measures

Name	Time	Method

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