A Study for Patient With Chronic Low Back Pain

Number of Responders: 50 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint

Response to treatment was defined as at least a 50% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score. BPI is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Response was assessed at endpoint.

Time frame: 12 weeks

Number of Sustained Responders at 12 Week Endpoint

Sustained responders: participants with ≥30% reduction of BPI average pain rating from baseline to endpoint and baseline to earlier visit than last visit and who maintain a ≥20% reduction of BPI average pain rating from baseline at every visit between last visit and earlier visit. BPI: a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Number of sustained responders was assessed at endpoint.

Time frame: 12 weeks

Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution

The results presented are the cumulative number of participants reaching each threshold of BPI average pain reduction. The thresholds are given as percent reductions in BPI average pain score from the baseline score. BPI: a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Number of participants under each threshold was assessed at endpoint.

Time frame: 12 weeks

Change From Baseline to 12 Weeks Endpoint in Clinical Global Impressions of Severity (CGI-S)

Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Least Squares Mean values were controlled for investigator and baseline severity.

Time frame: baseline, 12 weeks

Patient's Global Impression of Improvement (PGI-I) at 12 Weeks

A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Least Squares Mean values were controlled for investigator and baseline severity.

Time frame: 12 weeks

Change From Baseline to 12 Weeks in Roland Morris Disability Questionnaire

Roland-Morris questionnaire will be completed by the patient and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient is instructed to put a mark next to each appropriate statement. The number of statements marked will be added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). Least Squares Mean values were controlled for investigator and baseline severity.

Time frame: baseline, 12 weeks

Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form

The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety (Ten), depression-dejection (Dep), anxiety-hostility (Ang), fatigue (Fat), confusion (Con), and vigor (Vig). Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig) and ranges from 0 (least disturbed) to 80 (most disturbed).

Time frame: baseline, 12 weeks

Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey

The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). The score for each of the domain and component summary=0-100 (higher scores indicate better health status or functioning).

Time frame: baseline, 12 weeks

Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension

Generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1; higher scores indicate a better health state perceived by the patient. Participants were evaluated with the United Kingdom (UK) and the United States (US) population based index score.

Time frame: baseline, 12 weeks

Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI)

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. 1. Absenteeism 2. Presenteeism 3. Work productivity loss 4. Activity Impairment Scores range from 0 to 1 for each of the above 4 types; higher scores indicate greater impairment.

Time frame: baseline, 12 weeks

Participants Who Discontinued From Baseline to 12 Weeks

Reasons for discontinuation are listed in the participant flow.

Time frame: baseline, 12 weeks

Change From Baseline to 12 Weeks in Uric Acid

Least Squares Mean values were controlled for investigator.

Time frame: baseline, 12 weeks

Change From Baseline to 12 Week Endpoint in Albumin

Least Squares Mean values were controlled for investigator.

Time frame: baseline, 12 weeks

Change From Baseline to 12 Week Endpoint in Alkaline Phosphatase

Least Squares Mean values were controlled for investigator.

Time frame: baseline, 12 weeks

Change From Baseline to 12 Week Endpoint in Alanine Aminotransferase

Least Squares Mean values were controlled for investigator.

Time frame: baseline, 12 weeks

Change From Baseline to 12 Week Endpoint in Aspartate Aminotransferase

Least Squares Mean values were controlled for investigator.

Time frame: baseline, 12 weeks

Change From Baseline to 12 Week Endpoint in Creatinine

Least Squares Mean values were controlled for investigator.

Time frame: baseline, 12 weeks

Change From Baseline to 12 Week Endpoint in Total Protein

Least Squares Mean values were controlled for investigator.

Time frame: baseline, 12 weeks

Change From Baseline to 12 Weeks in Blood Pressure

Least Squares Mean values were controlled for investigator.

Time frame: baseline, 12 weeks

Change From Baseline to 12 Week Endpoint in Weight

Least Squares Mean values were controlled for investigator.

Time frame: baseline, 12 weeks

Change From Baseline to 12 Week Endpoint in Pulse Rate

Least Squares Mean values were controlled for investigator.

Time frame: baseline, 12 weeks

Number of Participants With Suicidal Ideation or Suicidal Behaviors According to the Columbia Suicide Severity Rating Scale

The Columbia Suicide Severity Rating Scale (C-SSRS) captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred.

Time frame: baseline through 12 weeks