Birmingham, AL (PRWEB) June 03, 2013
Patients may be included in the study if they meet all of the following criteria:
1. The patient has had moderate to severe chronic low back pain for at least 3 months duration before screening.
2. The patient is able to speak English and is willing to provide written informed consent, including a written opioid agreement, to participate in this study.
3. The patient is willing and able to successfully self-administer the study drug, comply with study restrictions, complete the electronic diary, and return to the study center for scheduled study visits, as specified in the protocol.
4. The patient is 18 through 80 years of age at the time of screening.
5. Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception, agree to continue use of this method for the duration of the study and for 30 days after participation in the study, and have a negative pregnancy test at screening. Acceptable methods of contraception include barrier method with spermicide, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method. NOTE: A woman will be considered surgically sterile if she has had a tubal ligation, hysterectomy, bilateral salpingo-oophorectomy or bilateral oophorectomy, or hysterectomy with bilateral salpingo-oophorectomy.
6. If the patient is receiving interventional therapies, physical therapy, biofeedback therapy, acupuncture therapy, or herbal remedies, these therapies must remain unchanged during the study.
7. The patient must not participate in any other study involving an investigational agent while enrolled in the present study.
The primary objective of this clinical study is to evaluate the efficacy of a new drug compared with placebo in alleviating moderate to severe pain in patients with chronic low back pain, as assessed by the change from baseline in the weekly average of daily worst pain intensity (WPI) scores at week 12, using an 11-point numerical rating scale (NRS-11).
The secondary objectives of the study are as follows:
1. To evaluate the efficacy of treatment with a new drug as compared with placebo in alleviating moderate to severe pain in patients with chronic low back pain, as measured by the following:
- change from baseline in the weekly average of daily average pain intensity (API) scores at week 12, based on an NRS-11 from an electronic diary
- time to loss of efficacy, defined as discontinuation of study drug for lack of efficacy
- percentage of patients with both a 30% or greater increase in API from baseline to the final on-treatment visit (defined as the last visit in which the patient is taking study drug during the double-blind treatment period) and an API score of 5 or higher at the final on treatment visit
- change from baseline to the final on-treatment visit in the Roland Morris Disability Questionnaire (RMDQ) score
2. To evaluate the safety and tolerability of treatment with a new drug, as assessed by the following:
- occurrence of adverse events throughout the study
- changes from the titration baseline visit in pure tone audiometry reviewed by the audiologist at visit 7 (day 0/baseline), the final on treatment visit, and the final study visit (week 12 or early termination)
- Subjective Opiate Withdrawal Scale (SOWS) scores, as calculated from data in electronic diaries, daily during the first 4 weeks of the double-blind treatment period up to the final on-treatment visit1
- Clinical Opiate Withdrawal Scale (COWS) scores at the visits at weeks 1, 2, and 4 (during the double-blind treatment period) up to the final on-treatment visit1
- clinical laboratory (serum chemistry, hematology, and urinalysis) test results at the final on-treatment visit and final study visit (week 12 or early termination)
- vital signs (blood pressure and pulse) measurements at each visit
- 12-lead electrocardiogram (ECG) findings at the final on-treatment visit and final study visit (week 12 or early termination)
- complete physical examination findings, including body weight measurements, at the final on-treatment visit and final study visit (week 12 or early termination)
- concomitant medication usage throughout the study
- Receive medical care at No Cost
- Health Insurance is not required
- Receive Compensation for time & travel
- Help Advance medical research
*Achieve Clinical Research conducts Clinical Research Trials in Alabama. For more information about participating in a Chronic Low Back Pain Clinical Study, please visit our website or contact us directly at (205) 380-6434.
*To see if you qualify for this Chronic Lower Back Pain Clinical Trial, visit Achieve Clinical Research on the web or contact us directly at (205) 380-6434.