Pain Clinical Trial Reports

December 11, 2012

Brief summaries of recently launched clinical trials for post-operative pain, low back pain, pelvic pain, migraine, and other forms of chronic pain.

Brief summaries of recently launched clinical trials for post-operative pain, low back pain, pelvic pain, migraine, and other forms of chronic pain.

Efficacy of Gralise for Chronic Pelvic Pain

Sponsor:

Rehabilitation Institute of Chicago

Study Drug:

Gralise (gabapentin)

Estimated Enrollment:

36

Condition:

Pelvic pain, prostatitis, interstitialcystitis, ulcerative colitis, irritable bowel syndrome

Study Site(s):

Illinois

This phase IV study will “investigate the pain relieving effects of the study drug Gralise (a novel long-acting gabapentinoid) for people who experience chronic pelvic pain.” Patients will use an electronic pain diary for 15 weeks to record their “worst pain of the day” and the average of three other pain scores using a pain numeric rating scale. Participants will “start at 600mg and titrate up by 600mg a week for two weeks (to 1800mg), then remain on 1800mg steady state dose of medication (or placebo pills) for 2 weeks. If intolerable side effects occur, the dose may be reduced to last tolerable dose.”

Study of Oxycodone DETERx vs. Placebo in Opioid-Experienced and Opioid-naive Subjects with Moderateto-Severe Chronic Low Back Pain

Sponsor:

Collegium Pharmaceutical, Inc.

Study Drug:

Oxycodone DETERx

Estimated Enrollment:

350

Condition:

Chronic low back pain

Study Site(s):

Arizona, Florida, Indiana, Kansas, New York, Ohio, Oklahoma, South Carolina, Virginia, Washington

Investigators will “evaluate the analgesic efficacy of Oxycodone DETERx compared with placebo in opioid-experienced and opioid-naive subjects with moderate-to-severe chronic low back pain.” The primary outcome measures will be the change in average pain intensity measured by the change in PI-NRS scores from baseline to Week 12 of the maintenance phase of the study. Participants will receive placebo or 40-160 mg total of oxycodone DETERx per day, divided into two doses.

Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 Mcg for the Treatment of Post-operative Pain in Patients after Knee or Hip Replacement Surgery

Sponsor:

AcelRx Pharmaceuticals, Inc.

Study Drug:

Sufentanil NanoTab PCA System

Estimated Enrollment:

440

Condition:

Postoperative pain

Study Site(s):

Florida

Investigators will evaluate the efficacy and safety of the Sufentanil NanoTab PCA System/15 mcg for the management of acute postoperative pain after total unilateral knee or total unilateral hip replacement surgery. The primary outcome measure will be the “timeweighted summed pain intensity difference (SPID) over the 48-hour study period.” Patients who have undergone a replacement of the same knee or hip, or “who have taken an opioid for more than 30 consecutive days, at a daily dose of 15 mg or more of morphine (or equivalent), within the past 3 months prior to surgery,” are ineligible.

Influence of Body Size and Composition on Response to Hydromorphone in ED Patients with Acute Pain

Sponsor:

Albert Einstein College of Medicine of Yeshiva University

Study Drug:

Hydromorphone

Estimated Enrollment:

200

Condition:

Acute pain

Study Site(s):

New York

This study will “examine the association between two measures of body size/body composition and response to a standard dose of hydromorphone. The null hypothesis is that there is no association between the measures of body size/composition and response to 1 mg hydromorphone, and thus no difference between the associations. If a strong association exists between TBW or BMI and pain response, it will lend support for the importance of taking body size or composition into account when making decisions about hydromorphone dosing in the ED. It will lay the groundwork for future studies of analgesic dosing. This is of particular importance given the increasing prevalence of obesity in the US and other developed nations.”

Effects of Testosterone Replacement on Pain Sensitivity and Pain Perception in Men with Chronic Pain Syndrome

Sponsor: Johns Hopkins University and Endo Pharmaceuticals

Study Drug: Fortesta (testosterone gel)

Estimated Enrollment: 70

Condition: Pain, low testosterone, hypogonadism

Study Site(s): Maryland

Researchers will study whether “testosterone replacement in men who take opioid-based pain medications and have low testosterone levels will show improvement in pain tolerance, pain perception and quality of life.” Primary outcomes measures are pain tolerance (measured using standard pressure pain, thermal pain perception, and cold pressor tests) and quality of life (measured using the Short Form-36 questionnaire).

Pharmacokinetic Study of MK-1602 in the Treatment of Acute Migraine

Sponsor:

Merck

Study Drug:

MK-1602, rescue medication

Estimated Enrollment:

192

Condition:

Migraine

Study Site(s):

Arizona, California, Florida, Indiana, Massachusetts, Missouri, New York, Ohio, Texas, Utah, Virginia

This study will attempt to “characterize the pharmacokinetics of MK-1602 in the treatment of acute migraine, including the influence of demographic and other variables on MK-1602 pharmacokinetics, and to evaluate the relationship between MK-1602 concentrations and efficacy of the drug.” Primary outcome measures include “dry blood spot” MK-1602 concentration two hours post-dose on migraine treatment day and pain freedom and relief two hours post-dose on migraine treatment day. Researchers will also monitor subjects for absence of phonophobia, photophobia, and nausea two hours post-dose, sustained pain freedom and/or relief from 2-24 hours post-dose on migraine treatment day, and total migraine freedom at two hours and at 2-24 hours post-dose on treatment day.