A Double-blind, Randomized, Placebo-controlled, Parallel, Multicenter Study of the Safety and Efficacy of Two Dosages of Bicifadine SR in Adult Outpatients with Chronic Neuropathic Pain Associated with Diabetic Peripheral Neuropathy
- Conditions
- Chronic neuropathic pain in patients with diabetic peripheral neuropathyMedDRA version: 9.1Level: LLTClassification code 10054095Term: Neuropathic pain
- Registration Number
- EUCTR2007-003638-40-DE
- Lead Sponsor
- XTL Development Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 336
1.Male or female, of any race, age 18 years or older
2.Diagnosis of type-I (insulin dependent) or type-II (non-insulin dependent) diabetes mellitus
3.Hemoglobin A1C of =11%
4.Evidence of chronic bilateral pain due to diabetic neuropathy, which is defined as pain in the legs or feet with decreased sensation in the feet or decreased/absent ankle jerk deep tendon reflexes
5.Neuropathy diagnosis confirmed by a score of =3 on the Michigan Neuropathy Screening Instrument (MNSI) Part B only.
6.Presence of pain due to chronic diabetic neuropathy for at least 6 months prior to the initial screening visit
7.The primary pain location must be in the feet
8.For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectable, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study
9.Subject must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
10.Subject must give written informed consent to participate. There must be evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent procedures of the study prior to performing any study procedures
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
1.Presence of other pain that could confound assessment or self-evaluation of the pain due to chronic diabetic neuropathy such as peripheral vascular disease (ischemic pain), neurological disorders unrelated to diabetic neuropathy (e.g., phantom limb pain from amputation), skin condition in the area of the neuropathy that could alter sensation (e.g., plantar ulcer), or other painful conditions (e.g., arthritis, fibromyalgia)
2.Symptoms of other painful conditions such as thoracic radiculopathy or lumbar radiculopathy that could confound assessment or self-evaluation of the pain due to chronic diabetic neuropathy
3.Presence of amputations other than toe amputations
4.History of lack of analgesic response to an adequate trial of duloxetine, venlafaxine, or tricyclic antidepressants (TCAs)
5.Score of >20 on the BDI
6.History of any clinically significant psychiatric or other neurological disorder other than diabetic neuropathy, headache, or migraine headache
7.Significant neurological or psychiatric symptoms resulting in disorientation, memory impairment, or inability to report accurately (e.g., Alzheimer’s disease or schizophrenia or other psychosis), that in the investigator’s opinion may affect efficacy or safety assessments or may compromise subject safety during the trial
8.History (within the last 10 years) of any seizure disorder or epilepsy
9.Any of the following within 1 year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm. Severe traumatic brain injury within the last 10 years
10.Use of the following medications (which could affect symptoms of pain due to chronic diabetic neuropathy) during the study: TCAs, selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin, other AEDs (such as carbamazepine), baclofen, mexiletine, capsaicin, tramadol, opioids, or other analgesics (except for acetaminophen up to 3 g/day and prophylactic aspirin up to 325 mg/day). All of these excluded medications require a washout period of appropriate length (according to the investigator) before the Screening II Visit.
11.Current evidence of clinically important diseases of gastrointestinal, hematopoietic, renal, respiratory, or cardiovascular systems; urinary retention; or glaucoma
12.Female subjects who are pregnant and/or breastfeeding or have a positive serum pregnancy test at the Screening or Baseline Visits
13.Positive urine drug screen for amphetamines, barbiturates, marijuana metabolites, cocaine metabolites, methadone, methaqualone, opiates, phencyclidine (PCP), or propoxyphene. However, a positive urine drug screen for benzodiazepines will not necessarily exclude the subject.
14.History of known alcohol or narcotic substance abuse within 2 years prior to the initial screening visit
15.History of any chronic illness other than diabetes that may interfere with or contraindicate participation in the study, as determined by the investigator
16.A body mass index (BMI) of greater than 40
17.Clinically-relevant illness within the 30 days prior to the initial screening visit that may interfere with the subject’s ability to complete the study
18.Participated in a previous clinical study of bicifadine
19.Any subject considering or scheduled to undergo any major surgical procedure during the study period
20.Any subject who has taken any other investigational drug during the 30 days prior to the initial screening v
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method