Clinical Trial Reports: May 2012

As part of our continued effort to provide pain professionals with the resources they need, PainLive presents summaries of ongoing clinical trials in a broad range of pain management topics.

Brain Morphometries in Patients with Osteoarthritis Treated with Duloxetine

Sponsor: Northwestern University, Eli Lilly and Company

Study Drug: Duloxetine

Estimated Enrollment: 60

Condition: Osteoarthritis

Study Site(s): Illinois

Several recent studies have indicated that “distinct chronic pain conditions” may be “associated with specific brain anatomical reorganization, characterized by regional decreases in grey matter density.” Other studies have shown that these changes to cerebral anatomy may be reversed with adequate analgesia. In this study, investigators will examine “the effects of treatment in relation to progression or regression of brain atrophy,” the extent to which “reversing atrophy corresponds to reversing plasticity at multiple levels in the nervous system,” as well as whether “such reversal also corresponds to improvements in cognitive and emotional abilities.” http://1.usa.gov/JlC0xa

Not Yet Recruiting

Study Comparing the Analgesic Efficacy and Safety of ABT-652 to Placebo in Subjects with Diabetic Neuropathic Pain

Sponsor: Abbott

Study Drug: ABT-652, duloxetine

Estimated Enrollment: 400

Condition: Diabetic neuropathic pain

Study Site(s): California, Connecticut, Massachusetts

Investigators will enroll adult patients who have a diagnosis of diabetes mellitus and a diagnosis of painful distal symmetric diabetic polyneuropathy and presence of ongoing pain due to diabetic peripheral neuropathy for at least 6 months. Participants in this 13- week study will be randomized to receive twice-daily ABT-652 (6, 12, or 18 mg), oncedaily duloxetine, or twice-daily placebo. The primary outcome measure will be 24- hour average pain score, measured using an 11-point Numeric Rating Scale. Subjects will also complete the Neuropathic Pain Symptom Inventory, Brief Pain Inventory, Neuropathic Pain Impact on Quality of Life Questionnaire, and other measures. http://1.usa.gov/K2DI59

Trial Comparing Buprenorphine and Methadone for Treatment in Opioiddependent Chronic Back Pain Patients

Sponsor: State University of New York at Buffalo

Study Drug: Buprenorphine/naloxone, methadone

Estimated Enrollment: 66

Condition: Low back pain

Study Site(s): New York

This study will compare buprenorphine and methadone “as a treatment of chronic pain in patients with chronic back pain who have developed an addiction to their prescription opioids.” Primary outcome measures will be pain interference (measured using the Brief Pain Inventory) and pain severity (measured using the Visual Analogue Scale). Participants will receive either buprenorphine/naloxone maintenance therapy or methadone for six months, to test the hypothesis that patients treated with buprenorphine/naloxone will “have superior outcomes as compared to those receiving methadone maintenance with respect to function, mental health, pain level, and treatment retention.” http://1.usa.gov/JqoBIU

Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate

Sponsor: Astellas Pharma Inc.

Study Drug: ASP015K, methotrexate

Estimated Enrollment: 375

Condition: Rheumatoid Arthritis

Study Site(s): California

This study will enroll adult patients who have been diagnosed with rheumatoid arthritis according to ACR criteria at least six months prior to enrollment, and who have been treated with oral methotrexate for at least 90 days (at a stable dose of 15-25 mg/week for a minimum of 28 days). Primary outcome measure will be the percentage of patients who achieve American College of Rheumatology Criteria 20 (ACR 20) response. Researchers will also measure patients’ trough plasma concentration of ASP015K and metabolites. http://1.usa.gov/ILXkf2

Intrathecal Therapy for Chronic Non-cancer Pain: An Analysis of Its Efficacy

Sponsor: Brigham and Women’s Hospital

Study Drug: Opioid (intrathecal, oral, and transdermal) and non-opioid analgesics

Estimated Enrollment: 90

Condition: Chronic Pain

Study Site(s): Massachusetts

Researchers will study patients who have a six-month+ history of chronic pain who have been receiving care at the Brigham and Women’s Hospital Pain Management Center for at least six months. The study will test two hypotheses: 1) that patients treated with intrathecal opioids for chronic noncancer pain “will report no improvement in treatment efficacy when compared to patients with chronic pain managed with oral or systemic opioid therapies,” and 2) that patients treated with intrathecal opioids “will report no improvement in treatment efficacy when compared to patients with chronic pain who are managed with nonopioid therapies.” http://1.usa.gov/IaC4yJ

Safety and Efficacy of AF-219 in Female Subjects with Interstitial Cystitis/Bladder Pain Syndrome

Sponsor: Afferent Pharamceuticals

Study Drug: AF-219

Estimated Enrollment: 150

Condition: Bladder Pain Syndrome

Study Site(s): Texas

This study will assess the efficacy and safety of four weeks of treatment with a singledose level of AF-219 in female subjects with moderate to severe interstitial cystitis/ bladder pain syndrome. The primary outcome measure will be the change from baseline in average pain score using a numerical pain rating scale. Participants will keep a pain/symptom diary, and will be assessed using the O’Leary-Sant Interstitial Cystitis Symptom and Problem indexes, as well as the Genitourinary Pain Index. http://1.usa.gov/HWrIn9