Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) |
Change from baseline in mean NRS-Pain scores at endpoint-BOCF. Daily pain scores were assessed on an 11-point numerical rating scale <(NRS)-Pain> ranging from 0 (no pain) to 10 (worst possible pain). Change from baseline in mean weekly pain scores was analyzed using longitudinal models assuming data were missing at random (MAR) |
Baseline, Weeks 1 - 14 and Endpoint-BOCF |
|
| Other |
Responders- Decreases of at Least 50% in Mean Weekly Pain Score |
Number of subjects that experienced at least a 50% decrease in mean weekly pain. |
Weeks 1-14 Endpoint BOCF (modified baseline observation carried forward) |
|
| Other |
Responders - Decreases of at Least 30% in Mean Weekly Pain Score |
Number of subjects that experienced at least 30% decrease in mean weekly pain. |
Weeks 1-14 endpoint BOCF |
|
| Other |
Duration Adjusted Average Change From Baseline in NRS Pain Scores |
Duration Adjusted Average Change(DAAC) in NRS-Pain score = (mean at observation - mean at baseline)x(proportion of planned study duration that the subject completed). |
Weekly: Week 1 - Week 14 |
|
| Primary |
Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline |
Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale <(NRS)-Pain> ranging from 0 (no pain) to 10 (worst possible pain). |
Baseline, Week 14 |
|
| Secondary |
Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices |
Change from baseline in MOS-Sleep subscales & Sleep Problem Indices. Twelve item subject-rated questionnaire assessing sleep constructs. Scores range from 0 - 100 and higher scores reflect more impairment. Subscales "sleep adequacy", "quantity of sleep" and "optimal sleep" low scores reflect impairment. |
Baseline, Week 14 |
|
| Secondary |
Change From Baseline for Hospital Anxiety and Depression Scale (HADS) Subscales |
Change from Baseline in scale at endpoint: normal (score 0) to severe (score 21). |
Baseline, Week 14 |
|
| Secondary |
Change From Baseline for Modified Brief Pain Inventory-Short Form (mBPI-sf) Scores |
Change from baseline to endpoint in the mBPI-sf to assess pain severity and pain interference with functional activities: 11-point scale ranging from "no pain" (0) to "pain as bad as you can imagine" (10) |
Baseline, Week 14 |
|
| Secondary |
Change From Baseline for NRS-Sleep Interference Scores |
11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]) |
Baseline, Week 14 |
|
| Secondary |
Categorized Patient Global Impression of Change (PGIC) |
The PGIC is a participant-rated instrument that measures change in the participants overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse). PGIC was evaluated using 3 categories of Improvement (Scores 1-3), No Change (Score 4), and Worsening (Scores 5-7). |
Baseline, Week 14 |
|
| Secondary |
Patient Global Impression of Change (PGIC) Rating |
PGIC is a participant-rated instrument that measures change in the participants overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse). |
Baseline, Week 14, Endpoint-LOCF |
|
| Secondary |
Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores |
Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. 10 pain descriptors questions answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). 2 items related to temporal pain assessed on 5-point scales. The NPSI derives 5 pain subscores & a total intensity score calculated from the 5 pain subscores |
Baseline, Week 14 |
|
| Secondary |
Change in Quantitative Assessment of Neuropathic Pain (QANeP) |
Change in a quantitative assessment of the participants' neuropathic pain were on an 11-point scale ranging from 0 (no pain) to 10 (most intense pain imaginable). |
Baseline, Week 14 |
|
| Secondary |
Change in NRS-Sleep Interference Scores |
Change in mean Pain-related sleep interference was assessed on an 11-point scale from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Weekly mean score was the sum of the daily diary scores divided by the number of diary entries during that week. |
Baseline, Weeks 1-14 |
|
| Secondary |
Shift in Hospital Anxiety and Depression (HADS) Subscales |
Anxiety subscale analyzes generalized anxiety (anxious mood,restlessness, anxious thoughts, panic attacks). The depression subscale focuses on the state of lost interest and diminished pleasure response. A score of Normal = 0-7, Mild = 8-10, Moderate = 11-14, Severe = 15-21. |
Baseline, Week 14 |
|
| Secondary |
Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours) |
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. |
Baseline, Weeks 1,2,6,10,14, Endpoint - LOCF |
|
| Secondary |
Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours) |
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. |
Baseline, Weeks 1,2,6,10,14, Endpoint-LOCF |
|
| Secondary |
Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours) |
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. |
Baseline, Weeks 1,2,6,10,14 and Endpoint |
|
| Secondary |
Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now) |
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. |
Baseline, Weeks 1,2,6,10,14 and Endpoint |
|
| Secondary |
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity) |
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. |
Baseline, Weeks 1,2,6,10,14 and Endpoint |
|
| Secondary |
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood) |
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. |
Baseline, Weeks 1,2,6,10,14 and Endpoint |
|
| Secondary |
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability) |
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. |
Baseline, Weeks 1,2,6,10,14 and Endpoint |
|
| Secondary |
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework) |
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. |
Baseline, Weeks 1,2,6,10,14 and Endpoint |
|
| Secondary |
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People) |
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. |
Baseline, Weeks 1,2,6,10,14 and Endpoint |
|
| Secondary |
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep) |
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. |
Baseline, Weeks 1,2,6,10,14 and Endpoint |
|
| Secondary |
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life) |
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. |
Baseline, Weeks 1,2,6,10,14 and Endpoint |
|
| Secondary |
Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain |
Number of subjects reporting duration of spontaneous pain. The NPSI includes the temporal item for assessment of duration of spontaneous, ongoing and paroxysmal pain. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint. |
Baseline-Week 14 (Endpoint) |
|
| Secondary |
Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks |
Number of subjects reporting pain attacks. The NPSI includes the temporal item for assessing the numbers of pain attacks. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint. |
Baseline-Week 14 (Endpoint) |
|
| Secondary |
Change in Number of Pain Attacks Compared to Baseline - NPSI (Neuropathic Pain Symptom Inventory) |
Change from baseline in the number of pain attacks at endpoint. The NPSI includes the temporal item for assessing the numbers of pain attacks. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint. |
Baseline, Week 14 |
|
| Secondary |
Duration of Spontaneous Pain-NPSI (Neuropathic Pain Symptom Inventory) |
Change from baseline to endpoint in the duration of spontaneous pain. The NPSI includes the temporal item for assessment of duration of spontaneous, ongoing and paroxysmal pain. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint. |
Baseline, Week 14 |
|
| Secondary |
Gracely Pain Scale Score |
The modified Gracely Pain Scale is a 13-point verbal rating scale based on sensory pain descriptors ranked by severity from nothing (rank = 0) to extremely intense (rank = 15). Subjects selected the verbal descriptors that best matched their average neuropathic pain during the last 24 hours prior to assessment. |
Week 14 |
|
| Secondary |
Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table |
Shift from baseline in maximum sensory thresholds (in grams representing the force equivalent of various sizes of von Frey filaments) as measured on QANeP. Improved - decrease in the maximum of the 3 trials at endpoint. Worsened - an increase. Note:Sensory Thresholds are the highest values of the 3 trials at baseline (Week=0) and endpoint (Week 14) |
Baseline-Week 14 (Endpoint) |
|
| Secondary |
Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table |
Shift from baseline in median sensory thresholds (designated as Weight) from 3 trials as measured on the QANeP. Improved - a decrease in the median of the three trials at endpoint. Worsened - an increase. Note: Sensory Thresholds are the highest values of the three Trials at both baseline (Week=0) and endpoint (Week 14). |
Baseline-Week 14 (Endpoint) |
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