Birmingham, Alabama (PRWEB) June 30, 2013
ESTIMATED STUDY DURATION:
16-19 weeks. This involves 5 28 days in screening followed by 16 weeks of blinded study drug treatment.

BACKGROUND & RATIONALE:
Chronic discomfort affects an estimated 116 million American adults– much 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 healthcare remedy expenses and lost productivity. Discomfort is a key driver for visits to physicians, a key purpose for taking medication, a significant trigger of disability, and a key issue in high quality of life and productivity. Given the burden of pain on human lives and its many economic and social consequences, relieving pain could be considered a national priority. Fibromyalgia individuals constitute a developing, main cohort of chronic pain sufferers, and finding successful treatments for this disease represents an urgent challenge each to the field of medicine and to the U.S. economy.

Fibromyalgia syndrome (FM) is a typical disorder estimated to have an effect on two to four% of the population. Although FM is predominantly identified by the presence of chronic widespread discomfort, patients with fibromyalgia typically experience a selection of other program symptoms such as fatigue, non-restorative sleep, morning stiffness and cognitive dysfunction they may also be diagnosed with other comorbid discomfort situations such as migraine, irritable bowel syndrome, temperomandibular joint disorder (TMJ), interstitial cystitis and chronic pelvic pain.

Major OBJECTIVES:
The primary objective of this study is to evaluate the security and efficacy of a new Fibromyalgia drug as a treatment for patients with main fibromyalgia. The primary efficacy outcome measure will be the patients self-reported 24-hour recall typical discomfort intensity, evaluated on an 11 point numerical rating scale, comparing alter from baseline benefits over 16 weeks of remedy with a new Fibromyalgia drug or placebo.

The safety and tolerability of therapy with a new Fibromyalgia drug will be compared to placebo by evaluation of important indicators, laboratory parameters, therapy-related adverse events (TEAEs), and discontinuations due to adverse events.

SECONDARY OBJECTIVES:
1. Comparison of the efficacy of a new Fibromyalgia drug versus placebo primarily based on the outcomes of the self-reported Patient Worldwide Impression of Adjust (PGIC). Efficacy will be defined by the percentage of patients who rate themselves as very a lot enhanced or much enhanced (i.e., scores of 1 or two on the 1-7 point scale) at the end of therapy.

two. Comparison of the efficacy of a new Fibromyalgia drug versus placebo on the 7-day recall discomfort query of the FIQ-R.

three. Comparison of the efficacy of a new Fibromyalgia drug versus placebo on the Revised Fibromyalgia Effect Questionnaire (FIQR) total score.

4. Comparison of the efficacy of a new Fibromyalgia drug versus placebo on the 24 hour recall typical pain intensity NRS score obtained at Weeks six and 12.

INCLUSION CRITERIA:

1. Prepared and in a position to study, realize, and sign the informed consent

two. Male or female, 18 -70 years of age, inclusive

3. Each and every female patient have to have a unfavorable urine pregnancy test at Screening and Baseline unless post-menopausal (defined as no menses for at least 1 year) or surgically sterile (s/p hysterectomy, bilateral oophorectomy or bilateral tubal ligation)

4. Females of kid-bearing prospective should be willing to use an efficient birth handle technique for the duration of the study. Women involved in same sex relationships or committed to sexual abstinence (e.g., for religious motives) will be excluded from this requirement.

Allowable contraceptive methods consist of: 
a. Oral, implantable, injectable or transdermal hormonal contraceptives (need to have been utilised for a minimum of 1 full cycle prior to administration of study drug) 
b. Intrauterine devices (IUD) 
c. Vasectomized companion 
d. Double barrier approach (male or female condom, sponge, diaphragm or vaginal ring with simultaneous use of spermicidal agent)

5. Diagnosis of principal fibromyalgia (FM) as defined by the 2010 American College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia

six. Patients need to be prepared and capable to withdraw from the following therapies: duloxetine, milnacipran, pregabalin, gabapentin, sodium oxybate, narcotics and opioids.

7. Sufferers need to have a damaging drug screen for narcotics and opioids prior to completion of the Baseline go to.

eight. Sufferers have to be willing and capable to withdraw and refrain from the use of other NSAIDs.

9. Certified individuals with mild or moderate depression ought to be clinically stable, with no threat of suicidal ideation or behavior, and the dose of allowed anti-depressants ought to have been stable for at least three months prior to screening.

ten. Individuals ought to not call for therapy with warfarin, lithium, amiodarone, isoniazid, phenytoin, fluconazole, probenecid or raloxifene.

11. At the Screening pay a visit to, patient must have a 24 hour recall average discomfort intensity score among 40 and 90 inclusive on a 100 mm VAS scale.

12. At the Baseline go to, the patient should have a 24 hour recall typical pain intensity score among four and 9 inclusive on an 11 point numerical rating scale.

13. In the opinion of the Investigator, the patient is prepared and in a position to comply with all protocol-specified needs

*To see if you qualify for this Fibromyalgia Clinical Trial in Alabama, pay a visit to Obtain Clinical Analysis on the internet (http://www.achieveclinical.com) or speak to us straight at (205) 380-6434.

*Accomplish Clinical Research conducts Phase II-IV Clinical Trials in Alabama. For a lot more information about participating in a Fibromyalgia Clinical Study, please visit our web site or speak to us straight at (205) 380-6434.





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