The primary objective of this study is 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).Additionally, this study will also explore the pharmacokinetic and pharmacogenetic characteristics of ABT-894 in the DNP population. - ND

Conditions: diabetic neuropathic pain
MedDRA version: 6.1Level: PTClassification code 10054095

Registration Number: EUCTR2007-001140-47-IT

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 70 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.
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 (minimum 1 complete menstrual cycle)
·A vasectomized partner
·Contraceptives (oral, parenteral or transdermal) for 3 consecutive months prior to study drug administration, or use of an intrauterine device
·Double-barrier method (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 £ 9. Subjects who have an HgbA1c > 9 and £ 11 may be included in the study upon the Investigator's consultation with the Abbott Medical Monitor.
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.
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. Subjects who have a diagnosis of fibromyalgia, but do not require treatment, may be included in the study upon the Investigator's consultation with the Abbott Medical Monitor.
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-selective 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 may be permitted upon discussion with the Abbott Medical Monitor.
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)
. Treated major depressive disorder within the past two years may be included upon the Investigator's consultation with the Abbott Medical Monitor.
·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 ³ 150 and/or a diastolic blood pressure ³ 100 at two consecutive visits (Screening and Baseline).
16.Subject has a clinically significant abnormal ECG 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.
(Criteria n. 19-32 omissis)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is 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: Additionally, this study will also 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