"Instead of being in the brain, the pathology consists of excessive sensory nerve fibers around specialized blood vessel structures located in the palms of the hands." - Dr. Frank L. Rice
Birmingham, Alabama (PRWEB) June 30, 2013
ESTIMATED STUDY DURATION:
16-19 weeks. This includes 5 – 28 days in screening followed by 16 weeks of blinded study drug treatment.
BACKGROUND & RATIONALE:
Chronic pain affects an estimated 116 million American adults-- more than the total affected by heart disease, cancer and diabetes combined. Chronic pain is estimated to cost the U.S. $560-635 billion annually in direct medical treatment costs and lost productivity. Pain is a major driver for visits to physicians, a major reason for taking medication, a major cause of disability, and a key factor in quality of life and productivity. Given the burden of pain on human lives and its many financial and social consequences, relieving pain could be considered a national priority. Fibromyalgia patients constitute a growing, major cohort of chronic pain sufferers, and finding effective treatments for this disease represents an urgent challenge both to the field of medicine and to the U.S. economy.
Fibromyalgia syndrome (FM) is a common disorder estimated to affect 2 to 4% of the population. Although FM is predominantly identified by the presence of chronic widespread pain, patients with fibromyalgia often experience a variety of other system symptoms such as fatigue, non-restorative sleep, morning stiffness and cognitive dysfunction; they may also be diagnosed with other comorbid pain conditions such as migraine, irritable bowel syndrome, temperomandibular joint disorder (TMJ), interstitial cystitis and chronic pelvic pain.
The primary objective of this study is to evaluate the safety and efficacy of a new Fibromyalgia drug as a treatment for patients with primary fibromyalgia. The primary efficacy outcome measure will be the patient’s self-reported 24-hour recall average pain intensity, evaluated on an 11 point numerical rating scale, comparing change from baseline results over 16 weeks of treatment with a new Fibromyalgia drug or placebo.
The safety and tolerability of treatment with a new Fibromyalgia drug will be compared to placebo by analysis of vital signs, laboratory parameters, treatment-related adverse events (TEAEs), and discontinuations due to adverse events.
1. Comparison of the efficacy of a new Fibromyalgia drug versus placebo based on the results of the self-reported Patient Global Impression of Change (PGIC). Efficacy will be defined by the percentage of patients who rate themselves as “very much improved” or “much improved” (i.e., scores of 1 or 2 on the 1-7 point scale) at the end of treatment.
2. Comparison of the efficacy of a new Fibromyalgia drug versus placebo on the 7-day recall pain question of the FIQ-R.
3. Comparison of the efficacy of a new Fibromyalgia drug versus placebo on the Revised Fibromyalgia Impact Questionnaire (FIQR) total score.
4. Comparison of the efficacy of a new Fibromyalgia drug versus placebo on the 24 hour recall average pain intensity NRS score obtained at Weeks 6 and 12.
1. Willing and able to read, understand, and sign the informed consent
2. Male or female, 18 -70 years of age, inclusive
3. Each female patient must have a negative urine pregnancy test at Screening and Baseline unless post-menopausal (defined as no menses for at least one year) or surgically sterile (s/p hysterectomy, bilateral oophorectomy or bilateral tubal ligation)
4. Females of child-bearing potential must be willing to utilize an effective birth control method for the duration of the study. Women involved in same sex relationships or committed to sexual abstinence (e.g., for religious reasons) will be excluded from this requirement.
Allowable contraceptive methods include:
a. Oral, implantable, injectable or transdermal hormonal contraceptives (should have been used for a minimum of one full cycle prior to administration of study drug)
b. Intrauterine devices (IUD)
c. Vasectomized partner
d. Double barrier method (male or female condom, sponge, diaphragm or vaginal ring with simultaneous use of spermicidal agent)
5. Diagnosis of primary fibromyalgia (FM) as defined by the 2010 American College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia
6. Patients must be willing and able to withdraw from the following therapies: duloxetine, milnacipran, pregabalin, gabapentin, sodium oxybate, narcotics and opioids.
7. Patients must have a negative drug screen for narcotics and opioids prior to completion of the Baseline visit.
8. Patients must be willing and able to withdraw and refrain from the use of other NSAIDs.
9. Qualified patients with mild or moderate depression should be clinically stable, without risk of suicidal ideation or behavior, and the dose of allowed anti-depressants should have been stable for at least three months prior to screening.
10. Patients should not require treatment with warfarin, lithium, amiodarone, isoniazid, phenytoin, fluconazole, probenecid or raloxifene.
11. At the Screening visit, patient must have a 24 hour recall average pain intensity score between 40 and 90 inclusive on a 100 mm VAS scale.
12. At the Baseline visit, the patient must have a 24 hour recall average pain intensity score between 4 and 9 inclusive on an 11 point numerical rating scale.
13. In the opinion of the Investigator, the patient is willing and able to comply with all protocol-specified requirements
*Achieve Clinical Research conducts Phase II-IV Clinical Trials in Alabama. For more information about participating in a Fibromyalgia Clinical Study, please visit our website or contact us directly at (205) 380-6434.