The study includes back pain of the cervical, thoracic, and the lumbar regions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
78
subjects will receive 1 study drug capsule by mouth twice daily for 3 weeks, followed by 1 capsule in the morning for 3 days.
subjects will receive 1 placebo capsule by mouth twice daily for 3 weeks, followed by 1 capsule in the morning for 3 days.
Annette C. Toledano MD
North Miami, Florida, United States
Change from Baseline in Brief Pain Inventory 24-hour Pain Scores for average pain (Question #5)
The Brief Pain Inventory is a self-reported medical questionnaire used to measure pain over the past 24-hours - worst pain (Question 3), least pain (Question 4), average pain (Question 5), right now pain (Question 6) and at night pain (Question 7). The score ranges from 0 to 10 (0 - no pain) (10 - intolerable pain).
Time frame: baseline to week 3
Change from Baseline in Brief Pain Inventory 24-hour assessment of interference in function (Questions 9a - 9i).
BPI Interference; questions 9a - 9i - measures a self-reported assessment of the interference in function because of pain in past 24 hours in general activity, mood, walking ability, normal work, relationship with other people, sleep quality, enjoyment of life, standing ability and sitting ability. Interference scores: 0 (does not interfere) to 10 (completely interferes).
Time frame: baseline to week 1, week 2 and week 3
Change From Baseline in Brief Pain Inventory 24-hour subject's Global Impression of Improvement (Question 8)
The Brief Pain Inventory question 8 measures the subject's perception of how much relief he has received at the time of assessment compared with before the start of the study drug. The score is measured in percentage 0% (no relief) to100% (complete relief).
Time frame: baseline to week 1, week 2 and week 3
Change From Baseline in the subject's Global Assessment of Treatment Satisfaction today
A self-reported scale that measures Treatment Satisfaction today in (0-10, 0 - none, 10 - most satisfied)
Time frame: baseline to week 1, week 2 and week 3
Change from Baseline in the subject's perception of Ability to Tolerate the study drug and the severity of side effects today.
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A self-reported scale that measures the ability to tolerate the study drug and the severity of side effects today in (0-10, 0 - No side effects, 10 - intolerable side effects)
Time frame: baseline to week 1, week 2 and week 3
Change From Baseline in Oswestry Disability Index and Neck Disability composite scores(ODI), to Week 1, Week 2, and Week 3
The Oswestry Low Back Pain Disability Questionnaire (Oswestry Disability Index) and Neck Disability composite assesses pain-related disability in persons with low back pain (LBP) and neck pain. The score is recorded in percentage of disability.
Time frame: baseline to week 1, week 2 and week 3
Change From Baseline in Roland Morris Disability Questionnaire composite scores(ODI), to Week 1, Week 2, and Week 3
The Roland Morris Disability Questionnaire consists of 24 statements and the subject is instructed to put a mark next to each appropriate statement. The total score ranges from 0 (no disability) to 24 (severe disability).
Time frame: baseline to week 1, week 2 and week 3
Change From Baseline in Vital Signs - systolic blood pressure, diastolic blood pressure, pulse rate and body mass index to Week 1, Week 2, and Week 3.
Time frame: baseline to week 1, week 2 and week 3
Change from Baseline to week 3 in Laboratory Assessments - Alkaline Phosphatase, Alanine Transaminase - ALT (SGPT), Aspartate transaminase - AST(SGOT), Bilirubin, Total, Serum Creatinine, Blood Urea Nitrogen, Serum Chloride, Potassium, HCO3
Time frame: baseline to week 1, week 2 and week 3
Change from Baseline in the investigator's Clinical Global Impression - Severity scale (CGI-S) to Week 1, Week 2, week 3 .
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the investigator to rate the severity of the subject's back pain at the time of assessment, relative to the investigator's past experience. Considering total clinical experience, the subject is assessed on severity of back pain at the time of rating 1, normal; 2, borderline; 3, mild; 4, moderate; 5, marked; 6, severe; or 7, extreme.
Time frame: baseline to week 1, week 2 and week 3
Change from Baseline in The investigator's Clinical Global Impression - Improvement scale (CGI-I) to Week 1, Week 2, week 3
The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale, the investigator will rate how much the patient's back pain has improved or worsened relative to a baseline state at the beginning of the study and rate as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Time frame: baseline to week 1, week 2 and week 3
Change from Baseline in the subject's answer to the question, "Are you better off today then the time before starting the study drug?, yes/no, by what percentage?
Answer, yes/no and by 0%-100% (0%-not at all better, 100% - very much better off
Time frame: baseline to week 1, week 2 and week 3
Change From Baseline in the subject's answer to the question " Have you been more / less active in the past 24 hrs, comparing to the period before initiating the study drug, please rate in %.
The subjects answer, one of the following choices, - 150%, -100%, -50%, - 25%, 0% - same activity level, +25%, +50%, +100%, +150%
Time frame: baseline to week 1, week 2 and week 3
Subject's response to the question, "Have you responded to the treatment?"
Subject's answer yes/no.
Time frame: baseline to week 1, week 2 and week 3
Subject's Global Assessment of Disease Activity Improved / No Change
The Subject answer either Improved or No Change.
Time frame: baseline to week 1, week 2 and week 3
Subject's Global Evaluation of Study Medication.
The subject chooses, 1 - Excellent, 2 - Very Good, 3 - Good, 4 - Fair, 5 - Poor
Time frame: baseline to week 1, week 2 and week 3
The Subject's Satisfaction with Pain Relief, 0 - 10.
The subject answers on a scale of 0-10, (0 - not satisfied, 10 - very satisfied).
Time frame: baseline to week 1, week 2 and week 3
The Subject's Satisfaction with Moving, Standing, Walking and Bending Ability Scale, 0-10.
The subjects answers on a scale of 0-10, (0 - not satisfied, 10 - very satisfied)
Time frame: baseline to week 1, week 2 and week 3.
Change from Baseline in Brief Pain Inventory 24-hour Pain Scores for worst pain, least pain, right now pain and night pain (Questions 3,4,6 & 7)
The Brief Pain Inventory is a self-reported medical questionnaire used to measure pain over the past 24-hours - worst pain (Question 3), least pain (Question 4), average pain (Question 5), right now pain (Question 6) and at night pain (Question 7). The score ranges from 0 to 10 (0 - no pain) (10 - intolerable pain).
Time frame: baseline to week 1, week 2 and week 3