New Phase 3 Paid Lower Back Pain Clinical Trial Now Enrolling at Avail Clinical Research in Central Florida; Accepting Male & Female Participants Age 18-75
The primary objective of this study is to evaluate the efficacy of a new drug compared with a placebo in opioid-experienced and opioid-naive subjects with moderate-to-severe Chronic Lower Back Pain.
Online, October 10, 2012 (Newswire.com) - Today, there isn't a 'one pill' treatment that either treats or cures back pain. At best there is a multidisciplinary approach that uses a combination of medication and lifestyle changes that seem to work to a degree.
In many cases patients who could benefit from investigational treatment often miss out on back pain clinical studies because their doctor isn't aware of a study in the area. In addition, there are some cases where patients feel they are going through so much they don't need to be treated like a 'guinea pig,' and nothing could be further from the truth.
These back pain clinical trials taking place in Florida are testing new treatment methods, which are being developed by pharmaceutical and bio-technical companies. They are designed specifically to test the safety and efficacy of treatments for humans. By volunteering for our fully supervised Florida back pain clinical study, you may receive new investigational back pain treatments that may help us all understand your condition.
**Avail Clinical Research is now enrolling for this Lower Back Pain Clinical Trial in Central Florida. To get started, visit http://www.availclinical.com or call us directly at (386) 310-1334.
STUDY TITLE
A Phase III, Multi-Center, Randomized, Double-blind, Placebo-Controlled, Safety, Tolerability, and Efficacy Study of a NEW DRUG Versus Placebo in Opioid- Experienced and Opioid-Naive Subjects with Moderate-to-Severe Chronic Low Back Pain.
OBJECTIVES
The primary objective of this study is to:
Evaluate the analgesic efficacy of a NEW DRUG compared with placebo in opioid-experienced and opioid-naive subjects with moderate-to-severe CLBP, requiring continuous around-the-clock (ATC) opioid analgesia for an extended period of time.
The secondary objectives of this study are to:
Evaluate safety and tolerability of a NEW DRUG compared with placebo in opioid-experienced and opioid-naive subjects with moderate-to-severe CLBP, requiring continuous ATC opioid analgesia for an extended period of time
Evaluate quality of life (SF-12v2)
Evaluate level of physical disability (Roland Morris Disability Questionnaire [RMDQ])
Evaluate global impression of change (Patient Global Impression of Change [PGIC])
Evaluate the total amount of rescue medication used (number of doses per day, number of doses per week, mg per day, total amount used in mg)
Evaluate the time-to-exit from the study for all causes
Conduct responder analyses, including the cumulative distribution of subjects with an improvement in pain intensity and the proportion of responders with at least a 30 % and at least a 50% reduction in pain intensity.
Evaluate weekly changes in pain intensity from Randomization Baseline to weeks 2, 4, 6, 8, and 10.
STUDY DESIGN
A randomized withdrawal, double-blind, placebo-controlled, enriched-enrollment, parallel-group, multicenter, 12-week study.
INCLUSION CRITERIA
Subjects eligible for enrollment in the study must meet all of the following criteria:
1) Must provide written informed consent prior to participation in the study.
2) Must have the ability to read and/or follow written and oral instructions and be willing and able to use an electronic diary, per protocol.
3) Must have the cognitive ability, at the discretion of the Investigator, to be able to correctly and consistently use the assessment tools
4) Must have the cognitive ability, at the discretion of the Investigator, to be able to complete all required study-related procedures per protocol.
5) Male or non-pregnant female 18-75 years of age (inclusive) at the time of consent.
6) Must have a clinical diagnosis of moderate-to-severe CLBP for a minimum of 6 months prior to screening.
7) Must have an average 24-hour pain intensity score ≥ 5 and ≤ 9 on an 11-point PINRS at the screening visit (Visit 1), on current opioid or non-opioid analgesic medication.
8) Must be classified as non-malignant and non-neuropathic (Class 1 and 2), neuropathic (Class 3), or symptomatic for more than 6 months after low back pain surgery (Class 9) based on the Quebec Task Force Scale score.
9) Must, in the Investigator's opinion, qualify for ATC opioid therapy for treatment of CLBP.
10) For opioid-naive subjects, must have moderate-to-severe pain warranting the use of opioid medication and have failed prior APAP and/or NSAID therapy and/or are unable to tolerate NSAIDs. Note: failure to respond to APAP and/or NSAIDs is defined as a subject who experiences moderate-to-severe pain (≥ 5 on an 11-point PI-NRS) while on APAP and/or NSAIDs.
11) Subjects agree to stop the use of all analgesics (including NSAIDs and COX-IIinhibitors)
other than study drug from the day of the first Titration Phase visit (Visit 2) through to the End-of-Study Visit/Early Discontinuation Visit.
12) Subjects are willing to discontinue all prohibited medications, including non-opioid medications used for low back pain. (If any medications require dose tapering, the medication must start to be discontinued at least 7 days prior to the start of the Titration Phase unless stated otherwise in the protocol).
13) Subjects agree to stop local regional pain treatments during the study (e.g., nerve/plexus blocks or ablation, neurosurgical procedures for pain control, botulinum toxin injections, or inhalation analgesia).
14) Adjunct therapy for back pain such as physical therapy, biofeedback therapy, transcutaneous electrical nerve stimulation (TENS), acupuncture, nutraceuticals, herbal remedies, and water aerobics must be unchanged for at least 4 weeks prior to the Screening Visit through the End-of-Study Visit/Early Discontinuation Visit.
15) Female subjects must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at Visit 2 (prior to the start of the Titration Phase).
16) Female subjects of childbearing potential will use an acceptable method of birth control. Acceptable birth control includes total abstinence from heterosexual intercourse, a vasectomized partner, contraceptives (oral, parenteral, or transdermal), intrauterine device, or double-barrier method including condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream. Subjects considered not of childbearing potential must be surgically sterile (total hysterectomy, bilateral salpingo-oophorectomy, or tubal ligation) or be more than one year post-menopausal, defined as a complete cessation of menstruation for at least one year.
17) Subjects must be in general good health based on screening physical examination (defined as the absence of any clinically relevant abnormalities), medical history, 12-lead ECG, and clinical laboratory values (hematology, chemistry, serology, and urinalysis).
DURATION OF STUDY
Screening Phase - up to 3 weeks
Titration Phase - up to 6 weeks
Double-blind Maintenance Phase - 12 weeks
Follow-up Phase - 2 weeks
Total Duration - up to 23 weeks
STUDY POPULATION
Male and female subjects 18-75 years of age with moderate-to-severe chronic low back pain (CLBP). Opioid-experienced and opioid-naive subjects will be eligible for participation. Opioid-experienced subjects are defined as those subjects who have been on a daily dose of opioid medication ≥ 30 mg of morphine sulfate equivalents (MSE) per day for a minimum of 14 days prior to the Screening Visit.
Note: Subjects must not be on opioid medication >240 mg of MSE per day. Opioid-naive subjects will not be on any opioid medication or will have taken ≤ 10 mg of MSE per day for the 14 days prior to the Screening Visit. Opioid-naive subjects must have moderate-to-severe pain warranting the use of opioid medication and have failed prior APAP and/or non-steroidal anti-inflammatory drug therapy (NSAID) (i.e., have moderate-to-severe pain [≥ 5 on an 11- point pain intensity - numerical rating scale {PI-NRS}] while on APAP and NSAIDs) or be unable to tolerate NSAIDs.
NUMBER OF SUBJECTS PLANNED
Approximately 700 subjects screened
Approximately 500 subjects entered into the Titration Phase
Approximately 350 subjects randomized in the Double-blind Maintenance Phase
Approximately 200 subjects completed the 12-week Double-blind Maintenance Phase