Pain, PerioperativePhase 3NCT00905437

Study To Investigate The Effectiveness Of Pregabalin For Management Of Patients Undergoing Total Hip Replacement

A Phase 3 study testing Pregabalin in people with Pain, Perioperative, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 7 sites in India.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is the investigate if pregabalin started a day before surgery and continued for 14 days post-operatively can reduce post-operative pain, relieve pre- and post-operative anxiety and sleep disturbances. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain, Perioperative
What is being tested?: Pregabalin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 72 participants
Where: 7 sitesIndia
Study dates: Nov 2009to Jul 2012
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The patient is undergoing a routine (i.e., expected to be uncomplicated) total primary or secondary hip replacement surgery performed under a standardized regimen of spinal anesthesia, and is expected to experience moderate to severe post-surgical pain in the absence of post-operative analgesia

Who cannot join

The patient is undergoing a revision to a previous hip replacement procedure, hip replacement procedure further to a road traffic accident with multiple injuries, or a procedure expected to last longer than 4 hours
The patient has a history of uncontrolled chronic disease or a concurrent clinically significant illness or medical condition, which in the Investigator's opinion, would contraindicate study participation or confound interpretation of the results

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

India7 sites

Pfizer Investigational Site
Ahmedabad, Gujarat, 380 015
Pfizer Investigational Site
Bangalore, Karnataka, 560 076
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, 500 033
Pfizer Investigational Site
Kanpur, Uttar Pradesh, 208 001
Pfizer Investigational Site
Kanpur, Uttar Pradesh, 208 002
Pfizer Investigational Site
Kolkata, West Bengal, 700 054
Pfizer Investigational Site
New Delhi, 110 017

Other trials in India

About this study

Official title: Randomized Double-Blind, Multi-Center Study Of Efficacy And Tolerability Of Pregabalin Versus Placebo As An Adjunct To Standard Of Care For Perioperative Management Of Patients Undergoing Total Hip Arthroplasty

Conditions: Pain, Perioperative
Being tested: Placebo, Pregabalin
Keywords: perioperative, pregabalin, total hip replacement, post-operative pain
Medical subject headings: Pain, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Placebo as an adjunct to standard of care
PregabalinDrug
75 mg BD for 14 days

Study groups in NCT00905437
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo as an adjunct to standard of care Receives: Drug: Placebo
Pregabalin	Active comparator	Pregabalin as an adjunct to standard of care Receives: Drug: Pregabalin

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Pain on Movement Score
Mean pain on movement score was defined as the mean of the pain on movement score over Days 1 to 5 post-surgery. Pain experienced by participant during passive flexion through 90 degree and passive abduction through 30 degree at operated hip joint was evaluated on a scale of 0 to 10 where, 0= no pain and 10= worst possible pain.
Measured: Every 12 hours from Day 1 to Day 5 post-surgery

Secondary outcomes (6)

Mean Daily Pain Score
Mean daily pain score was defined as the mean of daily pain score over Days 1 to 7 and Days 8 to 14 post-surgery. Daily Pain Rating Scale (DPRS): participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.
Measured: Day 1 to Day 7, Day 8 to Day 14 post-surgery
Mean Daily Sleep Interference Score
Mean daily sleep interference score was defined as the mean of daily sleep interference numeric rating scale (NRS) score over Days 1 to 5 post-surgery. Daily Sleep Interference Scale (DSIS): participant rated pain during past 24-hour period on NRS ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep). Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.
Measured: Day 1 to Day 5 post-surgery
Mean Anxiety Visual Analogue Scale (A-VAS)
Mean anxiety visual analogue scale (VAS) was defined as the mean of VAS score on the day of surgery and over Days 1 to 5 post-surgery. Participants measured their degree of anxiety over past 24 hours on a VAS of 0 to 100, where 0 = not at all anxious to 100 = extremely anxious.
Measured: Day 0 to Day 5 post-surgery
Time to Mobilization After Surgery
Participant was encouraged each day (from Day 3) to attempt walking depending upon the degree of pain on standing. The first day on which the participant was able to walk for 5 steps was the day of mobilization. Median time to mobilization (in hours) was calculated till the day of mobilization.
Measured: Day 1 to Day 5 post-surgery
Number of Participants With Rescue Medication Usage
Rescue medications were used for participants with moderate or severe resting pain. Fentanyl injection (25 microgram [mcg] intravenous bolus to a maximum dose of 3 milliliter/day), paracetamol tablet (15 milligram/kilogram orally to a maximum dose of 45 milligram/kilogram/day) were used as rescue medications.
Measured: Day 0 to Day 6 post-surgery
Number of Participants With Neuropathic Pain
ID Pain questionnaire was used to assess neuropathic pain. 6 items questionnaire, did pain feel like: (1)pins and needles (2)hot/burning (3)numb (4)electrical shocks (5)is pain made worse with touch of clothing or bed sheets (6)is pain limited to your joints. "Yes" response to questions 1-5 were scored as 1, while a "yes" response to question 6 was scored as -1. "No" response were scored as 0. Overall score range -1 to 5.Higher score more indicative of pain with a neuropathic component. Number of participants with score 2 or more (which indicated nerve pain) were reported.
Measured: Day 90, Day 180 post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009Jul 2012

First posted20 May 2009 (estimated)
Study startNov 2009
Primary completionJul 2012
Study completionJul 2012

Why it stopped: The Study was terminated on May 24th 2012 due to a slow recruitment rate. The study was not terminated for reasons of safety or efficacy.

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.
Other trials for Pain, PerioperativeStudies 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00905437
Sponsor's protocol ID: A0081229
Status last verified: Jan 2021
First submitted: 19 May 2009
Last updated: 28 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Double-Blind, Multi-Center Study Of Efficacy And Tolerability Of Pregabalin Versus Placebo As An Adjunct To Standard Of Care For Perioperative Management Of Patients Undergoing Total Hip Arthroplasty
ClinicalTrials.gov ID: NCT00905437
Acronym / sponsor ID: A0081229
Conditions: Pain, Perioperative
Keywords: perioperative, pregabalin, total hip replacement, post-operative pain
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: The Study was terminated on May 24th 2012 due to a slow recruitment rate. The study was not terminated for reasons of safety or efficacy.
Enrolment: 72 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 20 May 2009 (estimated)
Results: Posted 11 Jun 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo as an adjunct to standard of care
Pregabalin	Active comparator	Drug: PregabalinPregabalin as an adjunct to standard of care

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

The patient is undergoing a routine (i.e., expected to be uncomplicated) total primary or secondary hip replacement surgery performed under a standardized regimen of spinal anesthesia, and is expected to experience moderate to severe post-surgical pain in the absence of post-operative analgesia

Key exclusion criteria (2 listed)

The patient is undergoing a revision to a previous hip replacement procedure, hip replacement procedure further to a road traffic accident with multiple injuries, or a procedure expected to last longer than 4 hours
The patient has a history of uncontrolled chronic disease or a concurrent clinically significant illness or medical condition, which in the Investigator's opinion, would contraindicate study participation or confound interpretation of the results

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
PlaceboPlacebo as an adjunct to standard of care	Drug	Placebo
Pregabalin75 mg BD for 14 days	Drug	Pregabalin

Primary outcome

Mean Pain on Movement Score
Time frame: Every 12 hours from Day 1 to Day 5 post-surgery
Mean pain on movement score was defined as the mean of the pain on movement score over Days 1 to 5 post-surgery. Pain experienced by participant during passive flexion through 90 degree and passive abduction through 30 degree at operated hip joint was evaluated on a scale of 0 to 10 where, 0= no pain and 10= worst possible pain.

6 secondary outcomes

Mean Daily Pain Score
Time frame: Day 1 to Day 7, Day 8 to Day 14 post-surgery
Mean Daily Sleep Interference Score
Time frame: Day 1 to Day 5 post-surgery
Mean Anxiety Visual Analogue Scale (A-VAS)
Time frame: Day 0 to Day 5 post-surgery
Time to Mobilization After Surgery
Time frame: Day 1 to Day 5 post-surgery
Number of Participants With Rescue Medication Usage
Time frame: Day 0 to Day 6 post-surgery
Number of Participants With Neuropathic Pain
Time frame: Day 90, Day 180 post-surgery

Results and safety

Results posted to the registry on 11 Jun 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pregabalin	35	27
Placebo	37	27

Primary outcome: Mean Pain on Movement Score

Time frame: Every 12 hours from Day 1 to Day 5 post-surgery. Mean (Standard Error). Unit: Units on a scale

Measure	Pregabalin n = 27	Placebo n = 30
Value	4.0 (0.23)	3.9 (0.26)

Population analysed: Modified Intent to Treat (MITT) population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pregabalin	2 of 35 (5.7%)	23 of 35 (65.7%)	Not reported
Placebo	0 of 37 (0%)	22 of 37 (59.5%)	Not reported

Limitations and caveats (from the sponsor): As the enrollment rate was very low, the study was prematurely terminated. The number of enrolled participants was too low for meaningful formal statistical conclusions.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pregabalin in people with Pain, Perioperative, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 7 sites in India.

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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in India. 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 11 Jun 2013). 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?

Mean Pain on Movement Score (time frame: Every 12 hours from Day 1 to Day 5 post-surgery). 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 NCT00905437.

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 28 Jan 2021.