Pain, PostoperativePhase 3NCT00468845
Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo For Treatment Of Post-Surgical Pain From Hysterectomy
A Phase 3 study testing pregabalin (Lyrica) in people with Pain, Postoperative, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 42 sites in 9 countries.
Trial summary
To assess the efficacy of pregabalin compared to placebo on pain following hysterectomy , measured using subject reported assessments of pain. Read more about this study
- Who is it for?
- Ages 25 to 70 years, women only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- pregabalin (Lyrica)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 501 participants
- Where
- 42 sitesin 9 countries
- Study dates
- Jun 2007to Oct 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject will have elective total abdominal hysterectomy using a transverse incision with or without bilateral salpingo-oophorectomy. The total hysterectomy may, however, be cervix-sparing.
- The subject is expected to remain at the hospital (or intermediate care facility) for a minimum of 2 days following surgery.
- The subject's preoperative health is graded as the American Society of Anesthesiologist P1 to P2.
Who cannot join
- Subjects having vaginal hysterectomy (whether laparoscopically assisted or not)
- Subjects having additional procedures (such as those involving the bladder) at the same time as the total abdominal hysterectomy
- The use of nerve block, spinal anesthesia or epidural anesthesia for post-surgical pain control
- Subjects who have been using any opioid medications 2 weeks or more continuously within 3 months prior to the screening visit.
- The subject has taken any NSAID or any analgesic other than acetaminophen within 3 days prior to surgery or is unwilling to abstain from NSAIDs or other analgesics, except as specified in the protocol, during the study. (Subjects taking <325 mg per day of aspirin at a stable dose for at least 30 days before the first dose of study medication will be allowed to continue their aspirin regimen for the duration of the study).
Trial locations and contacts
42 sites in 9 countries.
42 sites in 9 countries
United States14 sites
Pfizer Investigational Site
Glendale, Arizona, 85308
Pfizer Investigational Site
Glendale, California, 91206
Pfizer Investigational Site
Houston, Texas, 77024
Pfizer Investigational Site
Houston, Texas, 77054
Pfizer Investigational Site
Miami, Florida, 33136-1096
Pfizer Investigational Site
Miami, Florida, 33136
Pfizer Investigational Site
Mobile, Alabama, 36608
Pfizer Investigational Site
Pasadena, California, 91105
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104
Pfizer Investigational Site
Phoenix, Arizona, 85020
Pfizer Investigational Site
Phoenix, Arizona, 85023
Pfizer Investigational Site
Phoenix, Arizona, 85027
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15213
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15232
South Africa7 sites
Pfizer Investigational Site
Cape Town, Western Cape, 7500
Pfizer Investigational Site
Johannesburg, Gauteng, 1829
Pfizer Investigational Site
Krugersdorp, Gauteng, 1752
Pfizer Investigational Site
Ladysmith, KwaZulu-Natal, 3370
Pfizer Investigational Site
Newcastle, KwaZulu-Natal, 2940
Pfizer Investigational Site
Parktown, 2193
Pfizer Investigational Site
Pretoria, Gauteng, 0157
United Kingdom5 sites
Pfizer Investigational Site
Birmingham
Pfizer Investigational Site
Edinburgh, Scotland, EH16 4SA
Pfizer Investigational Site
Leicester, Leicestershire, LE1 5WW
Pfizer Investigational Site
Liverpool, L8 7SS
Pfizer Investigational Site
Livingstone, EH54 6PP
Spain4 sites
Pfizer Investigational Site
Cadiz, 11009
Pfizer Investigational Site
Madrid, 28031
Pfizer Investigational Site
Madrid, 28046
Pfizer Investigational Site
Valencia, 46010
Canada3 sites
Pfizer Investigational Site
Calgary, Alberta, T2N 2T9
Pfizer Investigational Site
Montreal, Quebec, H2X 3J4
Pfizer Investigational Site
Sherbrooke, Quebec, J1H 5N4
Sweden3 sites
Pfizer Investigational Site
Lund, 221 85
Pfizer Investigational Site
Örebro, 701 85
Pfizer Investigational Site
Stockholm, 182 88
Thailand3 sites
Pfizer Investigational Site
Bangkoknoi, Bangkok, 10700
Pfizer Investigational Site
Muang, Changwat Khon Kaen, 40002
Pfizer Investigational Site
Muang, Chiang Mai, 50200
Hong Kong2 sites
Pfizer Investigational Site
Kowloon, 0
Pfizer Investigational Site
Shatin
About this study
Official title: A Multiple Dose, Randomized, Double-Blind Multicenter Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo In The Treatment Of Patients With Post-Surgical Pain From Hysterectomy
To assess the efficacy of pregabalin compared to placebo on pain following hysterectomy , measured using subject reported assessments of pain.
- Conditions
- Pain, Postoperative
- Being tested
- pregabalin (Lyrica), matched placebo
- Keywords
- pain after hysterectomy, amount of opioids used
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pregabalin (Lyrica)Drug
150 mg/day double blind (divided doses)
pregabalin (Lyrica)Drug
300 mg/day double blind (divided doses)
matched placeboDrug
matched placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: pregabalin (Lyrica) |
| 2 | Experimental | Not described Receives: Drug: pregabalin (Lyrica) |
| 3 | Placebo comparator | Not described Receives: Drug: matched placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 2 (24 hours post surgery [PS])
Secondary outcomes (35)
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.
Measured: Day 1 (day of surgery), up to 7 days PS, Discharge, 2 and 4 weeks PS
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.
Measured: Day 1, up to 7 days PS, 2 and 4 weeks PS
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.
Measured: 48 +/- 4 hours PS
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.
Measured: 48 +/- 4 hours PS
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.
Measured: 8, 16, 24, 32, 40, 48 hours PS
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.
Measured: 48 +/- 4 hours PS
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.
Measured: 24, 48 Hours PS, Discharge (day 3 up to day 7 PS)
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.
Measured: 0-24, 24-48, 48-72 hours PS
Non-opioid Rescue Medication - Paracetamol
The amounts of non-opioid rescue medications, paracetamol, used by the participants during the study, including anti-emetic medications.
Measured: 24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS,
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
Measured: 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)
Non-opioid Rescue Medication - Ibuprofen
The amounts of non-opioid rescue medications, ibuprofen, used by the participants during the study, including anti-emetic medications.
Measured: 24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS
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.
Measured: Baseline, every 8 hours (up to 232 hours) PS, and Discharge (Day 3-7 PS flexible)
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.
Measured: Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS)
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.
Measured: Day 2, 3, 4, 5, 6, 7, PS; week 2, 3, 4 PS
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.
Measured: Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS
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.
Measured: Daily post hospital discharge ( Day 2-7 PS), Week 2, 3, 4 PS
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.
Measured: Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS
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.
Measured: Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS
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.
Measured: Day 1
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.
Measured: Day 1 PS
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.
Measured: Day 2 PS
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.
Measured: Day 3 PS
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.
Measured: Day 4 PS
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.
Measured: Day 5 PS
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.
Measured: Discharge (day 3 up to day 7 PS)
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.
Measured: Day 7 PS
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.
Measured: Day 14 PS
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.
Measured: Day 28 PS
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.
Measured: Discharge (day 3 up to day 7 PS), Day 28 PS
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.
Measured: Discharge (day 3 up to day 7 PS), Day 28 PS
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.
Measured: Discharge (day 3 up to day 7 PS) and day 28 PS
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.
Measured: Day 1 up to Day 7 PS
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.
Measured: Day 1 up to Day 7 PS
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.
Measured: 3 and 6 Months PS
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.
Measured: Surgery Day, Day 1, 2, 3, 4, 5 PS, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2007 (estimated)
- Study startJun 2007
- Primary completionMay 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468845
- Sponsor's protocol ID
- A0081153
- Status last verified
- Jun 2011
- First submitted
- 1 May 2007
- Last updated
- 10 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Singla NK, Chelly JE, Lionberger DR, Gimbel J, Sanin L, Sporn J, Yang R, Cheung R, Knapp L, Parsons B. Pregabalin for the treatment of postoperative pain: results from three controlled trials using different surgical models. J Pain Res. 2014 Dec 23;8:9-20. doi: 10.2147/JPR.S67841. eCollection 2015.
PubMed 25565885
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose, Randomized, Double-Blind Multicenter Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo In The Treatment Of Patients With Post-Surgical Pain From Hysterectomy
- ClinicalTrials.gov ID
- NCT00468845
- Acronym / sponsor ID
- A0081153
- Conditions
- Pain, Postoperative
- Keywords
- pain after hysterectomy, amount of opioids used
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- May 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 3 May 2007 (estimated)
- Results
- Posted 26 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy of pregabalin compared to placebo on pain following hysterectomy , measured using subject reported assessments of pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: pregabalin (Lyrica) |
| 2 | Experimental | Drug: pregabalin (Lyrica) |
| 3 | Placebo comparator | Drug: matched placebo |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The subject will have elective total abdominal hysterectomy using a transverse incision with or without bilateral salpingo-oophorectomy. The total hysterectomy may, however, be cervix-sparing.
- The subject is expected to remain at the hospital (or intermediate care facility) for a minimum of 2 days following surgery.
- The subject's preoperative health is graded as the American Society of Anesthesiologist P1 to P2.
Key exclusion criteria (5 listed)
- Subjects having vaginal hysterectomy (whether laparoscopically assisted or not)
- Subjects having additional procedures (such as those involving the bladder) at the same time as the total abdominal hysterectomy
- The use of nerve block, spinal anesthesia or epidural anesthesia for post-surgical pain control
- Subjects who have been using any opioid medications 2 weeks or more continuously within 3 months prior to the screening visit.
- The subject has taken any NSAID or any analgesic other than acetaminophen within 3 days prior to surgery or is unwilling to abstain from NSAIDs or other analgesics, except as specified in the protocol, during the study. (Subjects taking <325 mg per day of aspirin at a stable dose for at least 30 days before the first dose of study medication will be allowed to continue their aspirin regimen for the duration of the study).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pregabalin (Lyrica)150 mg/day double blind (divided doses) | Drug | 1 |
| pregabalin (Lyrica)300 mg/day double blind (divided doses) | Drug | 2 |
| matched placebomatched placebo | Drug | 3 |
Primary outcome
Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf)
Time frame: Day 2 (24 hours post surgery [PS])
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.
35 secondary outcomes
Current Pain - Pain With Movement Caused by Sitting
Time frame: Day 1 (day of surgery), up to 7 days PS, Discharge, 2 and 4 weeks PS
Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test
Time frame: Day 1, up to 7 days PS, 2 and 4 weeks PS
Area Under the Curve (AUC) Pain - Pain With Movement Caused by Sitting
Time frame: 48 +/- 4 hours PS
Area Under the Curve (AUC) Pain - Pain With Movement Caused by Peak Expiratory Flow (PEF) Test
Time frame: 48 +/- 4 hours PS
Current Pain at Rest
Time frame: 8, 16, 24, 32, 40, 48 hours PS
Area Under the Curve (AUC) of Pain at Rest During the First Two Days of Hospital Stay
Time frame: 48 +/- 4 hours PS
Total Cumulative Dose of Opioids Following Surgery
Time frame: 24, 48 Hours PS, Discharge (day 3 up to day 7 PS)
Integrated Analgesic Score
Time frame: 0-24, 24-48, 48-72 hours PS
Non-opioid Rescue Medication - Paracetamol
Time frame: 24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS,
Anxiety Before and After Surgery
Time frame: 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)
Non-opioid Rescue Medication - Ibuprofen
Time frame: 24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS
Percent Change From Baseline in Peak Expiratory Flow
Time frame: Baseline, every 8 hours (up to 232 hours) PS, and Discharge (Day 3-7 PS flexible)
Timed Up-and-Go (TUG)
Time frame: Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS)
Average Daily Pain
Time frame: Day 2, 3, 4, 5, 6, 7, PS; week 2, 3, 4 PS
Worst Daily Pain
Time frame: Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS
Sleep Interference
Time frame: Daily post hospital discharge ( Day 2-7 PS), Week 2, 3, 4 PS
Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores
Time frame: Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS
Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores
Time frame: Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS
Participant Satisfaction With Study Medication - Surgery Day
Time frame: Day 1
Participant Satisfaction With Study Medication - Day 1 PS
Time frame: Day 1 PS
Participant Satisfaction With Study Medication - Day 2 PS
Time frame: Day 2 PS
Participant Satisfaction With Study Medication - Day 3 PS
Time frame: Day 3 PS
Participant Satisfaction With Study Medication - Day 4 PS
Time frame: Day 4 PS
Participant Satisfaction With Study Medication - Day 5 PS
Time frame: Day 5 PS
Participant Satisfaction With Study Medication - Discharge
Time frame: Discharge (day 3 up to day 7 PS)
Participant Satisfaction With Study Medication - Day 7 PS
Time frame: Day 7 PS
Participant Satisfaction With Study Medication - Day 14 PS
Time frame: Day 14 PS
Participant Satisfaction With Study Medication - Day 28 PS
Time frame: Day 28 PS
Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication
Time frame: Discharge (day 3 up to day 7 PS), Day 28 PS
Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication
Time frame: Discharge (day 3 up to day 7 PS), Day 28 PS
Quality of Life Using EuroQol (EQ-5D) Health State Profile
Time frame: Discharge (day 3 up to day 7 PS) and day 28 PS
Time to Meet Hospital Discharge Criteria
Time frame: Day 1 up to Day 7 PS
Time to Actual Discharge
Time frame: Day 1 up to Day 7 PS
Incidence of Chronic Post-operative Pain
Time frame: 3 and 6 Months PS
Total Clinically Meaningful Event (CME) Score
Time frame: Surgery Day, Day 1, 2, 3, 4, 5 PS, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25565885Singla NK, Chelly JE, Lionberger DR, Gimbel J, Sanin L, Sporn J, Yang R, Cheung R, Knapp L, Parsons B. Pregabalin for the treatment of postoperative pain: results from three controlled trials using different surgical models. J Pain Res. 2014 Dec 23;8:9-20. doi: 10.2147/JPR.S67841. eCollection 2015.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
42 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pregabalin (Lyrica) in people with Pain, Postoperative, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 42 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, South Africa, United Kingdom, Spain, Canada and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf) (time frame: Day 2 (24 hours post surgery [PS])). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00468845, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.