Study To Investigate The Effectiveness Of Pregabalin For Management Of Patients Undergoing Total Hip Replacement
This study has been terminated.
(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.)
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00905437
First received: May 19, 2009
Last updated: October 11, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain, Perioperative |
Drug: Placebo Drug: Pregabalin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Mean of the Pain on Movement scores obtained over Post-Op Days 1-5. The Pain on Movement assessments are performed using an 11-point Numeric Rating Scale [NRS] following passive flexion & adduction at hip joint at 12-hr interval intervals [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Mean of the Daily Pain Scores (11-point NRS) obtained on Post-Op Days 1-7, and mean of the Daily Pain Scores obtained on Post-Op Days 8-14 [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Mean of the Daily Sleep Interference Scores (11-point NRS) obtained on Post-Op Days 1-5 [ Time Frame: 5 days ] [ Designated as safety issue: No ]
- Mean of the Anxiety Visual Analog Scale (A-VAS) scores obtained from the assessment performed on the day of surgery through to Post-Op Day 5 [ Time Frame: 5 days ] [ Designated as safety issue: No ]
- Time to mobilization (day on which patient is able to walk 5 steps for the first time post-surgery) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
- Use of rescue analgesics administered on Post-Op Days 0 - 5 [ Time Frame: 5days ] [ Designated as safety issue: No ]
- Incidence of neuropathic pain as detected using the ID Pain questionnaire 3 & 6 months following the surgery [ Time Frame: 6 mths ] [ Designated as safety issue: No ]
- Safety & tolerability of pregabalin versus placebo in patients undergoing primary total hip arthroplasty [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 72 |
| Study Start Date: | November 2009 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Placebo as an adjunct to standard of care
|
Drug: Placebo
Placebo as an adjunct to standard of care
|
|
Active Comparator: Pregabalin
Pregabalin as an adjunct to standard of care
|
Drug: Pregabalin
75 mg BD for 14 days
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00905437
Locations
| India | |
| Pfizer Investigational Site | |
| Hyderabad, Andhra Pradesh, India, 500 033 | |
| Pfizer Investigational Site | |
| Ahmedabad, Gujarat, India, 380 015 | |
| Pfizer Investigational Site | |
| Bangalore, Karnataka, India, 560 076 | |
| Pfizer Investigational Site | |
| Kanpur, Uttar Pradesh,, India, 208 001 | |
| Pfizer Investigational Site | |
| Kanpur, Uttar Pradesh, India, 208 002 | |
| Pfizer Investigational Site | |
| Kolkata, West Bengal, India, 700 054 | |
| Pfizer Investigational Site | |
| New Delhi, India, 110 017 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00905437 History of Changes |
| Other Study ID Numbers: | A0081229 |
| Study First Received: | May 19, 2009 |
| Last Updated: | October 11, 2012 |
| Health Authority: | India: Drugs Controller General of India |
Keywords provided by Pfizer:
|
perioperative pregabalin total hip replacement post-operative pain |
Additional relevant MeSH terms:
|
Pregabalin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on May 16, 2013