Diabetic Neuropathic Pain
Conditions
Keywords
Diabetic neuropathic pain, Active controlled phase 2 study
Brief summary
To evaluate the safety and efficacy of ABT-652 compared to Placebo in subjects with diabetic neuropathic pain. People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.
Detailed description
A double blind, randomized, active- and placebo-controlled 13-week study. Duloxetine is added to evaluate assay sensitivity.
Interventions
DRUGABT-652 6 mg
6 mg capsules
DRUGABT-652 12 mg
12 mg capsules
DRUGABT-652 12 mg - 18 mg
12 mg - 18 mg capsules
DRUGPlacebo
Placebo capsules
DRUGDuloxetine
Duloxetine capsules
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subject is between the ages of 18-75 years with a diagnosis of diabetes mellitus and must have a diagnosis of painful distal symmetric diabetic polyneuropathy and presence of ongoing pain due to diabetic peripheral neuropathy for at least 6 months. * Subject must have a mean average score of greater than 4 on the 24 hour average pain score (0-10 numerical rating scale) prior to the Baseline Visit. * Subject has been on a medication for diabetic neuropathic pain for the past 3 months.
Exclusion criteria
* Subject has clinically symptomatic neuropathic pain conditions that cannot be distinguished from Diabetic Neuropathic Pain or interfere with the pain assessments of Diabetic Neuropathic Pain. * A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with Diabetic Neuropathic Pain assessments or other functions. * Subject has clinically significant abnormalities in clinical laboratory tests. * Subject has taken an opioid chronically, excluding tramadol within the last 3 months prior to Screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour Average Pain Score | 12 weeks | Weekly mean of 24-hour average pain score measured by a 11-point Numeric Rating Scale completed on subject's daily diary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuropathic Pain Symptom Inventory | 12 weeks | Measures severity of common neuropathic pain qualities (burning, pressure, squeezing) |
| Patient Global Impression of Change | 12 weeks | Captures the subject's evaluation of his/her overall general impression of feeling since beginning study medication |
| Brief Pain Inventory | 12 weeks | Capture the subject's severity of pain and interference |
| Neuropathic Pain Impact on Quality of Life Questionnaire | 12 weeks | Captures the subject's assessment of neuropathic pain and the effect it has on the quality of daily life |
| EuroQuality of Life - 5 Dimension -5 Level | 12 weeks | Capture's the subject's mobility, self-care, usual activity, pain/discomfort and anxiety/depression |
Countries
United States
Outcome results
None listed