| Primary | Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf) | Modified Brief Pain Inventory - Short Form (m-BPI-sf): participant rated 11-point Likert rating scale ranged from 0 (no pain) to 10 (worst pain imaginable). Least Square (LS) Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. | Modified intent-to-treat (mITT) population: participants who received at least 1 dose study drug, had at least 1 post baseline safety and efficacy evaluation, took all pre-surgery medication, had no complications during surgery with discontinuation, no PS infection with additional hospitalization/readmission, had primary efficacy measurement PS | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Day 2 (24 hours post surgery [PS]) | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0007.1± 0.18
- OG0017.2± 0.18
- OG0027.4± 0.18
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANOVA | | 0.1378 | Weighted Z-score test method of Fisher (1998) and Cui et al (1999)applied to maintain alpha level. A step down procedure for multiple comparisons to control the maximum experiment wise type I error rate at 0.05 level. 300mg tested prior to 150mg. | | | | | | 95 | | | | | | | Superiority or Other (legacy) | | | | |
|
| Secondary | Current Pain - Pain With Movement Caused by Sitting | Participant sat upright from supine position, followed by 120 second (sec) rest period, during which participant asked to rate pain with movement. Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. Current pain reported on 11 point Likert scale 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. | mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed; Results presented for only those timepoints PS where at least 4 participants in each treatment arm completed the questionnaire at baseline and respective time point. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Day 1 (day of surgery), up to 7 days PS, Discharge, 2 and 4 weeks PS | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Secondary | Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test | Current pain with movement caused by peak expiratory flow (PEF) test as reported by participant on 11 point Likert scale 0 (no pain) to 10 (worst pain). Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. PEF test performed 3 times, with 120sec rest periods in between. At beginning of each rest period, participant asked to rate pain caused by forced expiration. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. | mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed; Results presented for only those timepoints PS where at least 4 participants in each treatment arm completed the questionnaire at baseline and respective time point. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Day 1, up to 7 days PS, 2 and 4 weeks PS | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
|
| Secondary | Area Under the Curve (AUC) Pain - Pain With Movement Caused by Sitting | Time-normalized AUC of pain with movement caused by sitting reported by participants. Participant sat upright from supine position, followed by a 120sec rest period, during which the participant asked to rate pain with movement. Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. Current pain reported on 11 point Likert scale 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. | mITT; N=number of evaluable participants analyzed | Posted | | Least Squares Mean | Standard Error | Units on a scale | | 48 +/- 4 hours PS | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Secondary | Area Under the Curve (AUC) Pain - Pain With Movement Caused by Peak Expiratory Flow (PEF) Test | Time-normalized AUC of pain reported by participants with movement caused by PEF test. Pain reported by participant on 11 point Likert scale 0 (no pain) to 10 (worst pain). PEF test performed 3 times, with 120sec rest periods in between. At beginning of each rest period, participant asked to rate pain caused by forced expiration. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. | mITT; N=number of evaluable participants analyzed | Posted | | Least Squares Mean | Standard Error | Units on a scale | | 48 +/- 4 hours PS | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Secondary | Current Pain at Rest | Pain reported by participants at rest (numeric rating scale (NRS) - Current Pain) on an 11 point Likert scale 0 (no pain) - 10 (worst pain). Pain at rest during the hospital stay was assessed just before each Pain with Movement assessment. Assessment performed 3 times each day of hospital stay, with 1 of daily assessments at 24 (+/- 2 ) hour intervals from end of surgery. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. | mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed | Posted | | Least Squares Mean | Standard Error | Units on a scale | | 8, 16, 24, 32, 40, 48 hours PS | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Secondary | Area Under the Curve (AUC) of Pain at Rest During the First Two Days of Hospital Stay | Time-normalized AUC of pain reported by participants on 11 point Likert scale 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. | mITT; N=number of evaluable participants analyzed | Posted | | Least Squares Mean | Standard Error | Units on a scale | | 48 +/- 4 hours PS | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Secondary | Total Cumulative Dose of Opioids Following Surgery | Total cumulative dose was calculated as milligram (mg) of morphine equivalent and included opioids administered by any route. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. | mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed | Posted | | Least Squares Mean | Standard Error | milligram (mg) | | 24, 48 Hours PS, Discharge (day 3 up to day 7 PS) | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Secondary | Integrated Analgesic Score | The integrated analgesic score (a combination of opioid use and either worst pain, or pain at rest, or pain caused by sitting, or pain caused by forced expiration as defined by Silverman et al 1993) was the sum of percent differences from mean rank for pain and opioids and ranged from -200 to 200 where lower values represent improvement. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. | mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed | Posted | | Least Squares Mean | Standard Error | Units on a scale | | 0-24, 24-48, 48-72 hours PS | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Secondary | Non-opioid Rescue Medication - Paracetamol | The amounts of non-opioid rescue medications, paracetamol, used by the participants during the study, including anti-emetic medications. | mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed | Posted | | Mean | Standard Deviation | Grams (g) | | 24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS, | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Secondary | Anxiety Before and After Surgery | Participant anxiety reported on Visual Anxiety Scale (VAS), 0 (not at all anxious) to 100 (extremely anxious). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata | mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Surgery day before first dose and 1 hour after first dose, Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS) | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Secondary | Non-opioid Rescue Medication - Ibuprofen | The amounts of non-opioid rescue medications, ibuprofen, used by the participants during the study, including anti-emetic medications. | mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed | Posted | | Mean | Standard Deviation | Grams (g) | | 24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Secondary | Percent Change From Baseline in Peak Expiratory Flow | Change from baseline= PEF at x hours minus PEF at baseline; possible values ranged from 0-900 liters/minute (higher values indicated better lung function). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. | mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed; Results presented for only those timepoints PS where at least 4 participants in each treatment arm completed the questionnaire at baseline and respective time point. | Posted | | Least Squares Mean | Standard Error | L/min | | Baseline, every 8 hours (up to 232 hours) PS, and Discharge (Day 3-7 PS flexible) | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Secondary | Timed Up-and-Go (TUG) | Functional mobility test performed once a day at 24 hour intervals from surgery after the pain with movement assessment. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. | mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed | Posted | | Least Squares Mean | Standard Error | Seconds | | Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS) | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Secondary | Average Daily Pain | Post-discharge average pain as measured in daily participant diaries NRS an 11 point Likert scale ranged from 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. | mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Day 2, 3, 4, 5, 6, 7, PS; week 2, 3, 4 PS | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Secondary | Worst Daily Pain | Post-discharge worst pain as measured in daily participant diaries NRS an 11 point Likert scale that ranged from 0 (no pain) to 10 (pain as bad as you can imagine). LS Means from ANOVA model with terms of treatment, pooled center, salpingo-oophorectomy strata and baseline worst pain score. | mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed | Posted | | Mean | Standard Deviation | Units on a scale | | Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Secondary | Sleep Interference | Sleep interference post surgery measured daily in participant diaries; NRS of how pain interfered with sleep during the last 24 hours, ranged from 0 (does not interfere) to 10 (completely interferes). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. | mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Daily post hospital discharge ( Day 2-7 PS), Week 2, 3, 4 PS | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Secondary | Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores | m-BPI-sf: participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. | mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Other Pre-specified | Percentage of Participants With Wound Healing Complications - Discharge | Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication. | Safety population all participants who were administered at least one dose of double blind medication, and for whom at least one post-baseline safety evaluation was obtained were included. | Posted | | Number | | Percentage of participants | | Discharge (day 3 up to day 7 PS) | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Other Pre-specified | Percentage of Participants With Wound Healing Complications - Day 7 PS | Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication. | | Posted | | Number | | Percentage of participants | | Day 7 PS | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Secondary | Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores | m-BPI-sf: participant rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. | mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Other Pre-specified | Percentage of Participants With Wound Healing Complications - Day 14 PS | Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication. | | Posted | | Number | | Percentage of participants | | Day 14 PS | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Other Pre-specified | Percentage of Participants With Wound Healing Complications - Day 28 PS | Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication. | | Posted | | Number | | Percentage of participants | | Day 28 PS | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Secondary | Participant Satisfaction With Study Medication - Surgery Day | Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. | mITT; N=number of evaluable participants analyzed | Posted | | Number | | Percentage of participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Secondary | Participant Satisfaction With Study Medication - Day 1 PS | Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. | mITT; N=number of evaluable participants analyzed | Posted | | Number | | Percentage of participants | | Day 1 PS | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Secondary | Participant Satisfaction With Study Medication - Day 2 PS | Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. | mITT; N=number of evaluable participants analyzed; | Posted | | Number | | Percentage of participants | | Day 2 PS | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Secondary | Participant Satisfaction With Study Medication - Day 3 PS | Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. | mITT; N=number of evaluable participants analyzed | Posted | | Number | | Percentage of participants | | Day 3 PS | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Secondary | Participant Satisfaction With Study Medication - Day 4 PS | Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. | mITT; N=number of evaluable participants analyzed | Posted | | Number | | Percentage of participants | | Day 4 PS | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Secondary | Participant Satisfaction With Study Medication - Day 5 PS | Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. | mITT; N=number of evaluable participants analyzed | Posted | | Number | | Percentage of participants | | Day 5 PS | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Secondary | Participant Satisfaction With Study Medication - Discharge | Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. | mITT; N=number of evaluable participants analyzed | Posted | | Number | | Percentage of participants | | Discharge (day 3 up to day 7 PS) | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Secondary | Participant Satisfaction With Study Medication - Day 7 PS | Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. | mITT; N=number of evaluable participants analyzed | Posted | | Number | | Percentage of participants | | Day 7 PS | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Secondary | Participant Satisfaction With Study Medication - Day 14 PS | Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. | mITT; N=number of evaluable participants analyzed | Posted | | Number | | Percentage of participants | | Day 14 PS | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Other Pre-specified | Percentage of Participants With Wound Healing Complications - End of Treatment | Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication. | | Posted | | Number | | Percentage of participants | | Day 1 up to Day 28 PS | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Other Pre-specified | Incision Length Correlated With Worst Pain | Incision length (cm) correlated with worst pain. Worst pain ranged from 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center, salpingo-oophorectomy strata. | | Posted | | Least Squares Mean | Standard Error | Centimeter (cm) | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Secondary | Participant Satisfaction With Study Medication - Day 28 PS | Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. | mITT; N=number of evaluable participants analyzed | Posted | | Number | | Percentage of participants | | Day 28 PS | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
| |
| Secondary | Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication | Satisfaction with current pain medication ranged from 0 (worst possible response) to100 (best possible response). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. | mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Discharge (day 3 up to day 7 PS), Day 28 PS | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
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| Secondary | Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication | Impact of current pain medication response scale: 0 (worst possible response) to 100 (best possible response). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. | mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Discharge (day 3 up to day 7 PS), Day 28 PS | | | | ID | Title | Description |
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| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
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| Secondary | Quality of Life Using EuroQol (EQ-5D) Health State Profile | Participant rated questionnaire assessed current health for 6 domains: mobility/self-care/ usual activities/pain/discomfort/anxiety and depression. Scoring developed by EuroQol Group assigned a utility value for each domain in the profile. Scores ranged from 1 better health (no problems) to 3 worst health (eg, "confined to bed"). Score transformed and resulted in a total score range -0.594 to 1.000; higher score=better health state. Health profile scores estimated using Dolan computational algorithms 1997 and 2001. LS Means adjusted for treatment/pooled center/salpingo-oophorectomy strata. | mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Discharge (day 3 up to day 7 PS) and day 28 PS | | | | ID | Title | Description |
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| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
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| Secondary | Time to Meet Hospital Discharge Criteria | Mean time from end of surgery to meet protocol defined hospital discharge criteria: participant no longer received parental opioids, was able to dress and mobilize without assistance, and had normal intake of food and fluids. | | Posted | | Mean | Standard Error | Hours | | Day 1 up to Day 7 PS | | | | ID | Title | Description |
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| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
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| Secondary | Time to Actual Discharge | Mean time from end of surgery to actual hospital discharge. Participant was expected to remain at the hospital for a minimum of 2 days following surgery. | | Posted | | Mean | Standard Error | Hours | | Day 1 up to Day 7 PS | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
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| Other Pre-specified | Neuropathic Pain Symptom Inventory (NPSI) | Pain characteristics in participants who reported pain (mBPI-sf, NPSI); NPSI a participant rated questionnaire to evaluate different symptoms of neuropathic pain, burning spontaneous pain, pressing spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia at discharge. NPSI Total Score ranged from 0 to 0.5; NPSI subscales pain ranged from 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. | mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Discharge (day 3 up to day 7 PS) | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
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| Secondary | Incidence of Chronic Post-operative Pain | Chronic post-operative pain as a result of abdominal hysterectomy as reported by participants on PS questionaire of pain within last 24 hours in area affected by surgery. | mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed. Participants reported as no chronic pain in the 3 month visit were carried over to the missing data at 6 month visit. | Posted | | Number | | Percentage of participants | | 3 and 6 Months PS | | | | ID | Title | Description |
|---|
| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
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| Secondary | Total Clinically Meaningful Event (CME) Score | Total CME score calculated by summing the number of Clinically Meaningful Events (CMEs) across symptoms. CME for each symptom will be defined using the Opioid-Related Symptom Distress Scale (OR-SDS) a participant rated scale of symptoms within the last 24 hours. Total CME score could range from 0 to 9. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. | mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Surgery Day, Day 1, 2, 3, 4, 5 PS, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS | | | | ID | Title | Description |
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| OG000 | Pregabalin 150mg | Pregabalin 75 mg twice a day (150 mg/day total) | | OG001 | Pregabalin 300 mg | Pregabalin 150 mg twice a day (300 mg/day total) | | OG002 | Placebo | |
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