Clinical Trial Reports: August 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.

Cymbalta for Fibromyalgia: An Open-label Study to Assess Potential Mechanisms for Fibromyalgia in Peripheral Tissue Innervation That Could Predict Therapeutic Responsiveness to Cymbalta

Sponsor: University of California, San Diego

Study Drug: Cymbalta (duloxetine)

Estimated Enrollment: 30

Condition: Fibromyalgia

Study Site(s): California

Patients enrolled in this trial will undergo nerve histology to “determine if biopsied skin sample nerve ending morphology will be predictive of duloxetine efficacy.” Patients will also be assessed for decreased pain ratings following eight weeks of treatment. Patients in the treatment arm will undergo skin biopsy, followed by eight weeks of treatment consisting of 30 mg/ day oral duloxetine for one week, 60 mg/ day oral duloxetine for eight weeks, and 30 mg/day oral duloextien for one week (if needed). Women, age 18-70 years, with no major psychiatric disorders are eligible to participate.

http://1.usa.gov/QgCY4H

Phase II Study to Assess the Efficacy, Tolerability, and Safety of NKTR- 181 in Opioid-naïve Subjects with Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee

Sponsor: Nektar Therapeutics

Study Drug: NKTR-181

Estimated Enrollment: 200

Condition: Osteoarthritis of the knee

Study Site(s): Alabama, California, Florida, Indiana, Kansas, Massachusetts, Missouri, Nebraska, Nevada, New Jersey, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Utah, Wisconsin

Investigators will measure the mean change from the baseline pain score to the pain score at the end of the double-blind randomized treatment period, as well as time to discontinuation of medication. Patients in the treatment arm will receive twice-daily 100, 200, 300, or 400 mg of oral NKTR-181 (titration period of up to 30 days, randomization up to 24 days).

http://1.usa.gov/LCw7AQ

Phase II Study of LY2951742 in Patients with Migraine

Sponsor: Arteaus Therapeutics

Study Drug: LY2951742

Estimated Enrollment: 190

Condition: Migraine

Study Site(s): California, Massachusetts

Patients with migraine (as classified by the HIS International Classification of Headache Disorders II guidelines) will undergo a four-week assessment to establish a baseline for the type, frequency, and severity of migraine, receive treatment with subcutaneous 150 mg LY2951742 once every other week for 12 weeks, and then be followed for 12 weeks. Researchers will assess the mean change from baseline in the number of migraine and/or headache days, mean change in number of migraine attacks, and proportion of patients who respond to treatment. See the link below for a list of inclusion and exclusion criteria.

http://1.usa.gov/Q9F6wn

Trial Comparing Duration of Analgesia after Popliteal Fossa Sciatiac Nerve Block with Ropivacaine 0.5% When Combined with Placebo, Dexamethasone 4mg or Dexamethasone 8 mg

Sponsor: Baylor College of Medicine

Study Drug: Dexamethasone (used in nerve block)

Estimated Enrollment: 150

Condition: Foot pain

Study Site(s): Texas

Following foot and/or ankle surgery, patients will be treated for pain with a nerve block consisting of ropivacaine 0.5% plus 2 ml of either dexamethasone 4 mg or 8 mg. Researchers will assess whether this combination increases the duration of pain relief provided by popliteal sciatic nerve block, and determine whether there is a difference in efficacy between the 4 and 8 mg doses of dexamethasone. Patients will also be assessed for the amount of narcotic analgesics required for pain control during the first 24 hours after surgery.

http://1.usa.gov/MqgKLc

Not Yet Recruiting

Trial Assessing Conversion from Hydrocodone, Oxycodone CR, or Morphine SR to Tapentadol ER in Subjects with Moderate to Severe Chronic Low Back or OA Pain of the Hip or Knee

Sponsor: Janssen Scientific Affairs, LLC

Study Drug: Nucynta ER

Estimated Enrollment: 150

Condition: Chronic low back pain, osteoarthritis of the hip or knee

Study Site(s): Alabama, Arizona, California, Florida, Georgia, Indiana, Iowa, Kansas, Louisiana, Missouri, North Carolina, Ohio, Oklahoma, Texas, Utah

This open-label study will assess “the overall clinical experience in participants with moderate to severe chronic low back pain or OA pain of the hip or knee, after conversion from hydrocodone, oxycodone CR, and/or morphine SR, using dose-conversion ratios of 1:5, 1:5 and 1:2.5, respectively.” Patients will be treated for four weeks with Nucynta ER 100 to 250 mg every 12 hours. Researchers will measure change in pain intensity from baseline, quality of life, sleep quality, pain interference, extent of neuropathic pain, and other outcomes.

http://1.usa.gov/OMviBa

Not Yet Recruiting

Treatment of Complex Regional Pain Syndrome with Once-daily Gralise

Sponsor: Massachusetts General Hospital

Study Drug: Gralise (gabapentin)

Estimated Enrollment: 45

Condition: Complex Regional Pain Syndrome I (CRPS I)

Study Site(s): Massachusetts

Patients age 18 to 80 years who have had CRPS I for at least three months, have a VAS pain score of 5 or above at baseline, are Gralise-naïve, and agree to make no changes to their current pain medications during the study period are eligible to participate in this study. After eight weeks of treatment with the standard dose of Gralise (following a two-week titration period), subjects will be followed for up to one year and assessed for change in VAS scores and functional status, adverse effects, and dropout rate.

http://1.usa.gov/NGkUw3