Clinical Trial Reports: June 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.

Study of Various Medications for Musculoskeletal Low Back Pain: Defining the Added Benefit of Muscle Relaxants and Opioids

Sponsor: Montefiore Medical Center

Study Drug: Naproxen, Cyclobenzaprine, Oxycodone/acetaminophen

Estimated Enrollment: 323

Condition: Acute Low Back Pain

Study Site(s): New York

Investigators will evaluate whether “combining muscle relaxants or opioids with NSAIDs is more effective than NSAID monotherapy for the treatment of non-traumatic, non-radicular low back pain.” Patients who present with low back pain will be randomized to one of three treatment arms: a 10-day course of twicedaily naproxen 500 mg plus thrice-daily oxycodone 5-10 mg/acetaminophen 325- 650 mg; 10 days of twice-daily naproxen 500 mg plus thrice-daily cyclobenzaprine 5-10 mg; or 10 days of twice-daily naproxen 500 mg plus placebo. Primary outcome measure will be Roland Morris low back pain functional disability scale scores taken seven days after ED discharge. Patients with a history of frequent back pain or longterm pain medication use, and patients whose back pain has lasted longer than two weeks are ineligible.

http://1.usa.gov/Lj60OR

Cannabinoid Modulation of Pain

Sponsor: Yale University

Study Drug: THC, capsaicin

Estimated Enrollment: 120

Condition: Chronic Pain

Study Site(s): Connecticut

This trial will “test the effects of cannabinoids on pain response using a variety of human experimental pain models.” During the first phase, participants will receive THC (either 0.01 or 0.03 mg/kg) after capsaicin; during phase II, participants will receive THC first, followed by capsaicin. Primary outcome measure will be capsaicin-induced hyperalgesia (measured at baseline, 20 days after initiating treatment, and 120 days). Patients who are cannabis-naïve or who are currently taking analgesic medication are ineligible.

http://1.usa.gov/LnClys

Trial Evaluating Gabapentin for the Treatment of Small Fiber Neuropathic Pain in Patients with Fabry Disease

Sponsor: Genzyme and the University of Minnesota - Clinical and Translational Science Institute

Study Drug: Gabapentin

Estimated Enrollment: 15

Condition: Fabry Disease, Neuropathic pain

Study Site(s): Minnesota

Patients with Fabry disease “often complain of acroparesthesia, caused by small fiber neuropathy.” There is no standard of care for this condition, and limited information regarding effective treatments for small fiber neuropathic pain in Fabry disease. This trial will evaluate the “efficacy of gabapentin vs. placebo at controlling peripheral neuropathic pain and reducing the use of opioid analgesics,” as measured by the percent reduction in patients’ hydrocodone-acetaminophen use. Prospective patients must be 18 years of age or older, with a confirmed diagnosis of Fabry disease and current neuropathic pain. Patients who are pregnant, have a history of illicit drug use, or are experiencing suicidal thoughts at enrollment are ineligible.

http://1.usa.gov/KaBkAe

Study of Venlafaxine to Prevent Oxaliplatin-induced Neuropathy

Sponsor: Mayo Clinic

Study Drug: Venlafaxine

Estimated Enrollment: 50

Condition: Peripheral neuropathy

Study Site(s): Minnesota

This clinical trial is designed to evaluate whether “venlafaxine can prevent or ameliorate chronic, cumulative neurotoxicity associated with oxaliplatin in cancer patients receiving oxaliplatin, fluorouracil, leucovorin calcium (FOLFOX).” Investigators will also explore the effect of venlafaxine on acute neuropathy associated with oxaliplatin. Participants in the experimental arm of this study will receive “venlafaxine PO BID beginning on day 1 of and continuing through completion of FOLFOX.” Patients in the placebo arm will receive placebo PO BID beginning on day 1 of and continuing through completion of FOLFOX. Investigators will use the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-CIPN20 to measure changes in sensory neuropathy from baseline. Patients will be followed up at 1, 3, 6, 12, and 18 months. Visit the link below to view the extensive inclusion and exclusion criteria for this study.

http://1.usa.gov/MzZ41t

Not Yet Recruiting

Study to Investigate the Effectiveness of IV Acetaminophen Administered During Functional Endoscopic Sinus Surgery in Reducing the Use of Opiates to Treat Postoperative Pain

Sponsor: Cadence Pharmaceuticals and The University of Texas Health Science Center, Houston

Study Drug: IV Acetaminophen

Estimated Enrollment: 60

Condition: Chronic Sinusitis

Study Site(s): Texas

This study will investigate whether IV acetaminophen (Ofirmev) is “a safe and efficacious agent in reducing postoperative pain” following endoscopic sinus surgery. Investigators will measure changes in pain intensity using a visual analog scale at regular time intervals post-operatively. Patients in the experimental arm will receive a preoperative dose of 1000 mg IV acetaminophen 15 minutes prior to surgery, followed by another 1000 mg dose of IV acetaminophen administered four hours after the first dose. Rescue medication containing oxycodone plus 325 mg acetaminophen will also be provided. The placebo group will receive 100 mL of 0.9% normal IV saline 15 minutes prior to surgery and four hours after the first dose. Rescue medication will also be provided, and patients “will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours.”

http://1.usa.gov/L1cxv2