The Academy is pleased to provide you with access to information about the latest clinical trials in pain management.

~February 2007

New Clinical Trials February 2007
Below are abstracts of recent pain and pain management studies selected from the National Library of Medicine. Click on the link below each entry for the complete abstract.

Arthritis

Condition: Arthritis (Rheumatoid)
State: CA, FL, IL, IN, KY, MI, MO, NY, OK, PA, TN
Purpose: To evaluate the efficacy, safety and tolerability of CP-195543 and celecoxib dual therapy in subjects with rheumatoid arthritis

Condition: Arthritis (Rheumatoid)
State: FL, MD, MI
Purpose: We are seeking men and women who are taking methotrexate for rheumatoid arthritis but are still experiencing symptoms of stiff, tender and swollen joints to take part in a research study. The purpose of this research is to evaluate the effectiveness of an investigational medication on controlling the signs and symptoms of rheumatoid arthritis when taken in addition to methotrexate

Condition: Arthritis (Rheumatoid)
State: ?
Purpose:The purpose of this study is to evaluate an investigational drug, maraviroc in subjects with active rheumatoid arthritis receiving methotrexate (MTX). Maraviroc is an orally active, reversible, selective antagonist of the CCR5 receptor. It is thought that the receptor is involved in the normal inflammatory process and it may contribute to the abnormal inflammatory process seen in rheumatoid arthritis. In this study, it will be determined first if there is a drug-drug interaction with MTX and then a dose of maraviroc will be selected to assess the safety and efficacy of maraviroc in patients on stable doses of background MTX.

Condition: Arthritis (Rheumatoid)
State: ?
Purpose: The purpose of this study is to compare the efficacy of etanercept with usual disease-modifying anti-rheumatic drug (DMARD) therapy in the treatment of moderate to severe rheumatoid arthritis (RA) over 16 weeks.

Condition: Osteoarthritis (Hip or Knee)
State: AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, LA, MD, MA, MI, MO, NJ, NV, NY, NC, OH, OK, PA, TN, TX, VA
Purpose: The purpose of this study is to evaluate the efficacy of Kadian NT compared with placebo for treating moderate to severe chronic pain over a 12 week period.

Condition: Osteoarthritis
State: AL, AR, AZ, CA, CT, FL, ID, IN KS, LA, MD, MA, MI, MN, MO, NE, NJ, NC, OH, PA, RI, SC, TN, TX, VA, WA, WI
Purpose: This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.

Condition: Osteoarthritis (Hip or Knee)
State: CA
Purpose: This study will evaluate the safety and effectiveness of Kadian NT when taken for chronic pain over 22 weeks. Participants must be 21 or older, have a primary diagnosis of osteoarthritis of the hip or knee, and have required treatment for hip or knee pain within the last 90 days. All study related office visits, medical evaluations, and study medication will be provided to qualified participants at no cost.

Condition: Osteoarthritis
State: CO
Purpose: The Colorado Arthritis Center is currently eligible participants in a research study. The study will evaluate the safety of an experimental drug therapy in patients with osteoarthritis.

Condition: Osteoarthritis (Knee)
State: CO
Purpose: The Flexx study is a clinical research trial of an investigational treatment for osteoarthritis (OA) knee pain. OA is the most prevalent chronic joint disorder worldwide, with many individuals experiencing pain and disability. OA of the knee is the most common form of knee arthritis, and it is a leading cause of physical disability in the United States.

Condition: Osteoarthritis (Knee)
State: DE
Purpose: The five-year goal of this project is to investigate the effect of in-shoe wedged orthoses on lower extremity function in patients with knee osteoarthritis. In general, our aims address the immediate effects of orthoses, the long-term effects of orthoses, and the immediate and long-term treatment effects comparing medial versus lateral wedged orthoses. We hypothesize the wedged orthosis will result in altered gait mechanics that reflect a reduction in knee joint forces, reduced knee joint pain and increased function during weight bearing activities.

Condition: Osteoarthritis
State: FL
Purpose: Double-Blind,Randomized,Placebo-Controlled Efficacy & Safety Study of EUFLEXXA™ for Treatment of OA of the First CMC.

Condition: Osteoarthritis (Knee)
State: MA
Purpose: A randomized double-blind, placebo- and active-control, parallel-arm, phase III trial with controlled adjustment of dose to evaluate the efficacy and safety of CG5503 extended-release (ER) in subjects with moderate to severe chronic pain due to osteoarthritis of the knee.

Condition: Osteoarthritis
State: ?
Purpose:The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety of orally administrated CG5503 Extended Release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain due to osteoarthritis of the knee, in comparison with placebo and Oxycodone Controlled Release (CR).

Condition: Osteoarthritis
State: ?
Purpose: CE-224535 is a new medication being developed as an analgesic and anti-inflammatory agent for the treatment of the signs and symptoms of osteoarthritis (OA). The purpose of this study is to evaluate the analgesic and anti inflammatory efficacy and safety of CE 224,535 versus placebo and naproxen treatment in patients with OA knee pain.

Condition: Osteoarthritis
State: ?
Purpose: This study will evaluate the effect of AGG-523 administration on biomarkers related to osteoarthritis. Safety and tolerability of AGG-523 will also be assessed.

Back Pain

Condition: Back Pain
State: CA, CO, CT, FL, TX, WA
Purpose: A Prospective and Randomized Controlled Trial to Evaluate the Safety and Effectiveness of Total Facet Arthroplasty in the Treatment of Degenerative Spinal Stenosis.

Breast Diseases

Condition: Breast Pain (Fibrocystic Breast Disease)
State: LA
Purpose: This study will evaluate the safety and effectiveness of an experimental medication to treat cyclic breast pain associated with fibrocystic breast tissue. Candidates 18-50 may be included who have a fibrocystic breast condition, including the presence of at least one palpable structure involving at least 25 percent of one breast, who experience periodic breast pain, and who have unsuccessfully treated periodic breast pain with conservative measures such as local heat, non-prescription analgesics, and properly fitted garments. Patients may not have a history of thyroid disease, or have breast pain caused by anything other than a fibrocystic condition.

Chronic Pain (General)

Condition: Chronic Pain
State: MO
Purpose: Radiant Research is currently evaluating an investigational pain treatment for adults age 18 to 70 years old who suffer with moderate to severe chronic pain.

Cancer Pain

Condition: Cancer Pain
State: NY
Purpose: This study will evaluate an experimental drug for breakthrough pain. Candidates at least 18 may be included who have cancer-related pain, are not pregnant or breastfeeding, and do not have a cardiopulmonary disease that would increase risk of shortness of breath.

Fasciitis, Plantar

Condition: Plantar Fasciosis
State: AZ, CA, FL, GA, TX, VA
Purpose: To evaluate the magnitude of improvement in AOFAS Ankle-Hindfoot Scale score in symptomatic patients demonstrating ultrasonography evidence of plantar fasciosis following surgical microdebridement using the Topaz MicroDebrider compared to similar patients treated using physician directed conservative care.

Fibromyalgia

Condition: Fibromyalgia
State: AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MD, MI, MO, NJ, NC, NV, OH, OK, PA, RI, SC, TN, TX, WI
Purpose: The primary objective is to evaluate the long-term safety of desvenlafaxine succinate sustained-release (DVS SR) during open-label treatment in adult outpatients with fibromyalgia syndrome.

Condition: Fibromyalgia
State: AZ, CA, IL, PA, TX
Purpose: The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.

Condition: Fibromyalgia
State: SD
Purpose: Fibromyalgia (FMS) a condition marked by pain, fatigue, and memory complaints, is considered a chronic condition and is most commonly treated or managed using medications. Previous studies have found benefit in adding cognitive-behavioral therapy (CBT), a non-medication intervention, to standard care in order to obtain better outcomes in terms of improved functional status and symptom reduction. While the addition of CBT to standard care has been shown to be beneficial, it is not a form of therapy that is widely available to patients with FMS. CBT includes a variety of skills that can be taught to patients to help in the management of chronic illnesses. This protocol will examine the relative merits of providing these CBT skills to patients via an informational website. The website will contain the content of CBT, a social support capability, and data transfer capabilities. The addition of this website to standard care will be compared to standard care alone. This study is interested in assessing improvements in physical functional status, the symptoms of FMS, and the relative costs of the interventions as compared to the savings in health care utilization over a 12-month period.

Condition: Fibromyalgia
State: PA, SC, TX
Purpose: The objective of this trial is to evaluate the safety and efficacy of Xyrem® compared to placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled, parallel group trial.

Female Urogenital Diseases

Condition: Endometriosis
State: AZ
Purpose: Advanced Clinical Therapies is currently recruiting participants for a clinical research study of an invetigational medication that is being tested for the management of endometriosis and the re-current pelvic pain and painful periods Conditions: Pelvic Pain, Painful Periods

Condition: Endometriosis
State: NJ
Purpose: If you are a female, 18-45 years old and have been diagnosed with endometriosis, Phoenix Ob-Gyn is seeking volunteers to take part in a clinical research study to treat Endometriosis Pain.

Neck Pain

Condition: Neck Pain
State: CA
Purpose: A Study to evaluate the effectiveness the Lidoderm 5% Topical Patch in treating pain and dysfunction in people with cervical facet joint osteoarthritis -- whiplash. Volunteers should not have a history of bleeding ulcer, renal insufficiency or failure, gastroesophageal disease, cancer of the neck, or current skin break down around neck area.

Phantom Limb

Condition: Phantom Limb Pain
State: TX
Purpose: This is a study to assess the possible benefit of duloxetine in the treatment of chronic phantom limb pain.

Pelvic Pain

Condition: Dysmenorrhea
State: AZ
Purpose: Advanced Clinical Therapies is currently recruiting participants for a clinical research study of an invetigational medication that is being tested for the management of endometriosis and the re-current pelvic pain and painful periods

Condition: Pelvic Pain
State: AZ
Purpose: Advanced Clinical Therapies is currently recruiting participants for a clinical research study of an invetigational medication that is being tested for the management of endometriosis and the re-current pelvic pain and painful periods.

Shoulder Pain

Condition: Shoulder Pain
State: TX
Purpose: The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with tendonitis or bursitis of the shoulder, elbow or knee.

Urologic Diseases

Condition: Interstitial Cystitis
State: MI
Purpose: Interstitial cystitis (IC) affects more than one million women in the United States. It has been thought that IC patients who have been unable to obtain adequate relief from medical remedies would value a psychotherapeutic intervention that could diminish some of their pain. There are currently no studies using biomarkers with the use of a relaxation technique called guided imagery in IC patients. Many guided imagery intervention studies in areas such as cancer, post-operative pain, and arthritis reported that guided imagery resulted in improvements in the psychological or physiological outcomes examined. If this is also true in IC patients, this intervention may prevent the use of unnecessary medications and procedures that are currently being used.


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