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Pregabalin for Osteoarthritis Pain
Phase 4
Waitlist Available
Led By Lee Kral, Pharm. D.
Research Sponsored by University of Iowa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 6 weeks
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial tests if pregabalin can help reduce pain and improve function in patients with an overactive pain response undergoing knee replacement surgery. Pregabalin works by calming the nerves, making them less sensitive to pain. Pregabalin is a well-accepted treatment option for patients with nerve pain.
Who is the study for?
This trial is for people aged 50-85 with severe primary osteoarthritis needing knee replacement surgery, who are non-smokers for over two years and score at least 40 on the Central Sensitization Inventory. Excluded are those taking high doses of opioids, with poor kidney function, pregnant women or potential to become pregnant, prisoners, non-English speakers, suicidal individuals or current/recent users of pregabalin.
What is being tested?
The study tests if pregabalin can improve pain and function in patients with central sensitization undergoing total knee arthroplasty (TKA). Participants will either receive standard care or add pregabalin before and after surgery. They'll be monitored through physical therapy assessments and surveys about their pain levels and opioid use.
What are the potential side effects?
Possible side effects from pregabalin include dizziness, sleepiness, dry mouth, swelling in limbs, blurred vision, weight gain and difficulty concentrating. Patients will report any adverse effects they experience during the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 6 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Calculate the Change Using the Knee Osteoarthritis Outcome Survey- Activities of Daily Living Subscale
Secondary study objectives
Calculate the Change Using the Knee Osteoarthritis Outcome Survey-Sports and Recreational Activities
Calculate the Change Using the Knee Osteoarthritis Outcome Survey-Stiffness
Calculate the Change Using the Knee Osteoarthritis Outcome Survey-Symptoms
+6 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Study (Pregabalin)Experimental Treatment1 Intervention
Participants will receive pregabalin orally 75mg twice daily x 7 days prior to surgery, 150mg twice daily x 7 days after surgery, followed by 75mg twice daily x 7 days. Then Stop.
Group II: ControlActive Control1 Intervention
Participants will receive standard peri-operative pain management
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pregabalin 75mg
2011
Completed Phase 4
~690
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Pregabalin, a common treatment for Central Sensitization Syndrome (CSS), works by modulating the release of neurotransmitters to reduce pain and central sensitization. This is particularly important for CSS patients because the condition involves an increased sensitivity of the central nervous system to pain stimuli.
By decreasing the abnormal pain signaling, pregabalin helps alleviate the heightened pain response. Other treatments for CSS may include anticonvulsants and antidepressants, which also aim to modulate neurotransmitter activity and reduce central nervous system hyperactivity.
Pregabalin suppresses nociceptive behavior and central sensitization in a rat trigeminal neuropathic pain model.Pregabalin attenuates place escape/avoidance behavior in a rat model of spinal cord injury.
Pregabalin suppresses nociceptive behavior and central sensitization in a rat trigeminal neuropathic pain model.Pregabalin attenuates place escape/avoidance behavior in a rat model of spinal cord injury.
Find a Location
Who is running the clinical trial?
University of IowaLead Sponsor
470 Previous Clinical Trials
894,760 Total Patients Enrolled
15 Trials studying Osteoarthritis
4,861 Patients Enrolled for Osteoarthritis
Lee A. KralLead Sponsor
Lee Kral, Pharm. D.Principal InvestigatorUniversity of Iowa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 50 and 85 years old.I have been taking a strong painkiller daily for the last month.I am currently taking pregabalin or have had a bad reaction to it before.I do not understand English.I am scheduled for a surgery to replace or fix my artificial joint.I am having a knee replacement due to severe arthritis.I have not smoked for over 2 years.My kidney function is low, with a GFR under 30 ml/min.I am pregnant or able to become pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Study (Pregabalin)
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.