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

~August 2007

New Clinical Trials August 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.

Arizona

Fibromyalgia
City: Phoenix
Purpose: Purpose of the study is to evaluate the safety and effectiveness of the study medication that is administered twice daily as compared to placebo in female patients with fibromyalgia syndrome.

Nervous System Diseases
City: Phoenix
Purpose: This is a randomized, double-blind, multicenter study to determine the effectiveness and safety of 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks compared with placebo in patients with DPN. The study hypothesis is that 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks will be more effective than placebo in reducing pain due to DPN, as measured by average daily DPN pain scores.

California

Arthritis
City: Los Angeles
Purpose: This study will evaluate the effects of walking aids in hip OA by examining gait biomechanics, quality of life, pain, and opinions regarding using a cane.

Fibromyalgia
City: Los Gatos
Purpose: Purpose of the study is to evaluate the safety and effectiveness of the study medication that is administered twice daily as compared to placebo in female patients with fibromyalgia syndrome.

Fibromyalgia
City: Oxnard
Purpose: Purpose of the study is to evaluate the safety and effectiveness of the study medication that is administered twice daily as compared to placebo in female patients with fibromyalgia syndrome.

Cancer Pain
City: Laguna Hills
Purpose: A Study to Evaluate the Effectiveness and Safety of CG5503 in the Treatment of Chronic Tumor Related Pain Compared With Placebo and Morphine

Endometriosis
City: San Diego
Purpose: Clinical trial studying an investigational medication to treat Endometriosis Pain

Headache Disorders
City: Sacramento
Purpose: Migraine and PFO closure Trial

Nervous System Diseases
City: Cupertino
Purpose: A study evaluating the safety and of treating Postherpetic Neuralgia patients with an ipioid patch, Bupivacaine TTS (Eladur ™ .)

Nervous System Diseases
City: Loma Linda, Los Angeles, Santa Monica
Purpose: This is a randomized, double-blind, multicenter study to determine the effectiveness and safety of 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks compared with placebo in patients with DPN. The study hypothesis is that 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks will be more effective than placebo in reducing pain due to DPN, as measured by average daily DPN pain scores.

Connecticut

New Haven
City: WW
Purpose: A Study to Evaluate the Effectiveness and Safety of CG5503 in the Treatment of Chronic Tumor Related Pain Compared With Placebo and Morphine

Nervous System Diseases
City: Fairfield
Purpose: This is a randomized, double-blind, multicenter study to determine the effectiveness and safety of 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks compared with placebo in patients with DPN. The study hypothesis is that 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks will be more effective than placebo in reducing pain due to DPN, as measured by average daily DPN pain scores.

District of Columbia

Nervous System Diseases
City: District of Columbia
Purpose: This is a randomized, double-blind, multicenter study to determine the effectiveness and safety of 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks compared with placebo in patients with DPN. The study hypothesis is that 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks will be more effective than placebo in reducing pain due to DPN, as measured by average daily DPN pain scores.

Florida

Arthritis
City: Miramar
Purpose: 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.

Arthritis
City: Vero Beach
Purpose: 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.

Cancer Pain
City: St. Petersburg
Purpose: A Study to Evaluate the Effectiveness and Safety of CG5503 in the Treatment of Chronic Tumor Related Pain Compared With Placebo and Morphine

Fibromyalgia
City: Jacksonville
Purpose: Purpose of the study is to evaluate the safety and effectiveness of the study medication that is administered twice daily as compared to placebo in female patients with fibromyalgia syndrome.

Fibromyalgia (Site 1)
City: Orlando
Purpose: Purpose of the study is to evaluate the safety and effectiveness of the study medication that is administered twice daily as compared to placebo in female patients with fibromyalgia syndrome.

Fibromyalgia (Site 2)
City: Orlando
Purpose: Purpose of the study is to evaluate the safety and effectiveness of the study medication that is administered twice daily as compared to placebo in female patients with fibromyalgia syndrome.

Nervous System Diseases
City: DeLand
Purpose: Test study medication in treatment of Painful Diabetic Peripheral Neuropathy

Georgia

Fibromyalgia
City: Atlanta
Purpose: Purpose of the study is to evaluate the safety and effectiveness of the study medication that is administered twice daily as compared to placebo in female patients with fibromyalgia syndrome.

Illinois

Analgesics, Non-Narcotic
City: Champaign
Purpose: Testing an investigational combination of two well-known medicines for pain relief and stomach protection in one pill

Endometriosis
City: Champaign
Purpose: Clinical research study to treat endometriosis pain

Fibromyalgia
City: Chicago
Purpose: Purpose of the study is to evaluate the safety and effectiveness of the study medication that is administered twice daily as compared to placebo in female patients with fibromyalgia syndrome.

Nervous System Diseases
City: Chicago
Purpose: This is a randomized, double-blind, placebo-controlled, parallel-group study. This is a 5-arm, 21-week study comprised of up to a 2-week Screening period, a 15-week dose-escalation and maintenance phase using 4 doses of E2007 (2 mg, 4 mg, 6 mg, and 8 mg) or placebo, and a 4-week, single-blind placebo follow-up phase. Patients will be randomly assigned to one of the five treatment groups. Those patients assigned to receive either 4 mg, 6 mg, or 8 mg E2007 will be escalated to the appropriate dose according to an escalation schedule. All patients will take four identical-looking tablets on a daily basis for the entire study duration for blinding purposes.

Indiana

Arthritis
City: Munster
Purpose: 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.

Cancer Pain
City: Elkhart, Indianapolis
Purpose: A Study to Evaluate the Effectiveness and Safety of CG5503 in the Treatment of Chronic Tumor Related Pain Compared With Placebo and Morphine

Kentucky

Arthritis
City: Lexington
Purpose: 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.

Louisiana

Cancer Pain
City: Shreveport
Purpose: A Study to Evaluate the Effectiveness and Safety of CG5503 in the Treatment of Chronic Tumor Related Pain Compared With Placebo and Morphine

Maryland

Back Pain
City: Baltimore
Purpose: The purpose of this research proposal is to conduct a feasibility study to determine the viability a larger efficacy study of combined acupuncture treatments plus treadmill exercise to decrease pain, facilitate exercise, and improve function in Veterans with chronic low back pain

Massachusetts

Analgesics, Opioid
City: Boston
Purpose: A research study to see if Ultram ER, an FDA-approved pain medication, would be helpful in providing pain relief in subjects whose chronic pain is not well controlled on narcotic pain medicine.

Analgesics, Opioid
City: Boston
Purpose: The study is looking at the effect of opioid (narcotic) pain medicines on pain sensation, threshold and tolerance.

Nervous System Diseases
City: Boston
Purpose: This is a randomized, double-blind, multicenter study to determine the effectiveness and safety of 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks compared with placebo in patients with DPN. The study hypothesis is that 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks will be more effective than placebo in reducing pain due to DPN, as measured by average daily DPN pain scores.

Nervous System Diseases
City: Ann Arbor
Purpose: This is a randomized, double-blind, multicenter study to determine the effectiveness and safety of 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks compared with placebo in patients with DPN. The study hypothesis is that 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks will be more effective than placebo in reducing pain due to DPN, as measured by average daily DPN pain scores.

Pelvic Pain
City: Boston
Purpose: Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) is a common condition with no known cure. It is estimated that every 15 seconds, a man in the USA is diagnosed with CP/CPPS. Studies have suggested that the condition may be genetic and passed down (or inherited) from one generation to the next. In this study we are comparing different families’ samples and medical information to determine which genetic factors may play a role in CP/CPPS

Michigan

Arthritis
City: Kalamazoo
Purpose: 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.

Minnesota

Nervous System Diseases
City: Minneapolis
Purpose: This is a randomized, double-blind, multicenter study to determine the effectiveness and safety of 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks compared with placebo in patients with DPN. The study hypothesis is that 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks will be more effective than placebo in reducing pain due to DPN, as measured by average daily DPN pain scores.

Missouri

Nervous System Diseases
City: St. Louis
Purpose: This is a randomized, double-blind, multicenter study to determine the effectiveness and safety of 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks compared with placebo in patients with DPN. The study hypothesis is that 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks will be more effective than placebo in reducing pain due to DPN, as measured by average daily DPN pain scores.

New Hampshire

Neck Pain
City: Concord
Purpose: The purpose of this follow-up study in which patients will be randomly assigned to receive thoracic spine thrust manipulation followed by therapeutic exercises or therapeutic exercise alone will be to investigate the validity of the previously developed CPR. If the CPR is indeed meaningful, patients who are positive on the CPR and receive thoracic spine thrust manipulation should experience improved outcomes compared to patients who are negative on the CPR and receive thoracic spine manipulation, and compared to patients who are positive on the CPR but receive the intervention believed to be effective for another subgroup of patients with neck pain.

New Jersey

Fibromyalgia
City: Nutley
Purpose: Purpose of the study is to evaluate the safety and effectiveness of the study medication that is administered twice daily as compared to placebo in female patients with fibromyalgia syndrome.

New Mexico

Fibromyalgia
City: Albuquerque
Purpose: Purpose of the study is to evaluate the safety and effectiveness of the study medication that is administered twice daily as compared to placebo in female patients with fibromyalgia syndrome.

New York

Cancer Pain
City: Glen Falls, Great Neck, Cedarhurst
Purpose: A Study to Evaluate the Effectiveness and Safety of CG5503 in the Treatment of Chronic Tumor Related Pain Compared With Placebo and Morphine

Headache Disorders
City: New York
Purpose: Severe Migraine Headaches in Adults

Nervous System Diseases
City: New York
Purpose: This is a randomized, double-blind, multicenter study to determine the effectiveness and safety of 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks compared with placebo in patients with DPN. The study hypothesis is that 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks will be more effective than placebo in reducing pain due to DPN, as measured by average daily DPN pain scores.

North Carolina

Cancer Pain
City: Winston-Salem
Purpose: A Study to Evaluate the Effectiveness and Safety of CG5503 in the Treatment of Chronic Tumor Related Pain Compared With Placebo and Morphine

Fibromyalgia
City: Monroe
Purpose: Purpose of the study is to evaluate the safety and effectiveness of the study medication that is administered twice daily as compared to placebo in female patients with fibromyalgia syndrome.

Nervous System Diseases
City: Winston-Salem
Purpose: This is a randomized, double-blind, multicenter study to determine the effectiveness and safety of 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks compared with placebo in patients with DPN. The study hypothesis is that 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks will be more effective than placebo in reducing pain due to DPN, as measured by average daily DPN pain scores.

North Dakota

Nervous System Diseases
City: Fargo
Purpose: A Study to Determine if an Investigational Pain Medicine Provides Relief of Chronic Pain After a Shingles Outbreak

Ohio

Headache Disorders
City: Cincinnati
Purpose: Purpose: clinical research study of an investigational drug for the treatment of Migraines

Fibromyalgia
City: Toledo
Purpose: Study of an investigational medication for Fibromyalgia

Nervous System Diseases
City: Toledo
Purpose: This is a randomized, double-blind, multicenter study to determine the effectiveness and safety of 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks compared with placebo in patients with DPN. The study hypothesis is that 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks will be more effective than placebo in reducing pain due to DPN, as measured by average daily DPN pain scores.

Pennsylvania

Nervous System Diseases
City: Duncansville
Purpose: A Study to Determine if an Investigational Pain Medicine Provides Relief of Chronic Pain After a Shingles Outbreak

Nervous System Diseases
City: Philadelphia, Upland
Purpose: This is a randomized, double-blind, multicenter study to determine the effectiveness and safety of 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks compared with placebo in patients with DPN. The study hypothesis is that 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks will be more effective than placebo in reducing pain due to DPN, as measured by average daily DPN pain scores.

South Carolina

Headache Disorders
City: Mount Pleasant
Purpose: Migraine Research Study

Tennessee

Arthritis
City: Memphis
Purpose: 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.

Headache Disorders
City: Memphis
Purpose: The purpose of this research study is to evaluate an investigational auto-injector system for delivering sumatriptan under the skin for a single migraine attack

Fibromyalgia
City: Memphis
Purpose: Purpose of the study is to evaluate the safety and effectiveness of the study medication that is administered twice daily as compared to placebo in female patients with fibromyalgia syndrome.

Texas

Cancer Pain
City: Colleyville, Houston
Purpose: A Study to Evaluate the Effectiveness and Safety of CG5503 in the Treatment of Chronic Tumor Related Pain Compared With Placebo and Morphine

Cancer Pain
City: Houston
Purpose: Explore the feasibility of a collaborative effort by oncology nurses to collect pain and symptom data across multiple institutions that care for ambulatory cancer patients in the TMC.

Fibromyalgia
City: Austin
Purpose: Purpose of the study is to evaluate the safety and effectiveness of the study medication that is administered twice daily as compared to placebo in female patients with fibromyalgia syndrome.

Nervous System Diseases
City: Amarillo
Purpose: This is a randomized, double-blind, multicenter study to determine the effectiveness and safety of 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks compared with placebo in patients with DPN. The study hypothesis is that 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks will be more effective than placebo in reducing pain due to DPN, as measured by average daily DPN pain scores.

Pain Measurement
City: Houston
Purpose: During the IR procedure, nurses commonly ask patients to tell them what their pain level is on a 0-10 scale. For those who participate in the study, these numbers will be used to calculate average pain levels. Study participants will be asked to complete the same 0-10 pain scale during the recovery period until time of discharge or admission to the hospital. According to standard criteria when giving conscious sedation, patients will remain in a communicable state throughout the procedure and during the recovery period prior to discharge, and thus, will be able to express a pain level during these times. The same questionnaire will be given for seven days after the procedure, which will be completed on a self-addressed, stamped postcard to be mailed back to UTMDACC. The last postcard will have a couple of questions about patient satisfaction. Once the last postcard is mailed in, the patient's participation in the study is over. Each questionnaire should take less than 5 minutes to complete.

Utah

Headache Disorders
City: Salt Lake City
Purpose: Clinical research study for treatment of teenagers with migraine

Virginia

Nervous System Diseases
City: Alexandria, Norfolk
Purpose: This is a randomized, double-blind, multicenter study to determine the effectiveness and safety of 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks compared with placebo in patients with DPN. The study hypothesis is that 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks will be more effective than placebo in reducing pain due to DPN, as measured by average daily DPN pain scores.

Washington

Analgesics, Opioid
City: Seattle
Purpose: ffect of Garlic Supplements on Opioids in Healthy Volunteers

Cancer Pain
City: Spokane
Purpose: A Study to Evaluate the Effectiveness and Safety of CG5503 in the Treatment of Chronic Tumor Related Pain Compared With Placebo and Morphine

Wisconsin

Nervous System Diseases
City: Madison
Purpose: This is a randomized, double-blind, multicenter study to determine the effectiveness and safety of 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks compared with placebo in patients with DPN. The study hypothesis is that 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks will be more effective than placebo in reducing pain due to DPN, as measured by average daily DPN pain scores.


American Academy of Pain Management is the nation's largest interdisciplinary organization serving clinicians who treat people with pain through education, setting standards of care, and advocacy.
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