Your session is about to expire
← Back to Search
Other
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
Study Summary
This trial will test if pregabalin use before and after TKA can reduce pain and improve function in patients with central sensitization.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Calculate the Change Using the Knee Osteoarthritis Outcome Survey- Activities of Daily Living Subscale
Secondary outcome measures
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 moreTrial 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
~610
Find a Location
Who is running the clinical trial?
University of IowaLead Sponsor
446 Previous Clinical Trials
879,482 Total Patients Enrolled
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Pregabalin been approved by the FDA for medical use?
"Safety associated with Study (Pregabalin) scored a 3 on the scale of 1-3. This is because it has achieved Phase 4 status, signifying its approval by medical authorities."
Answered by AI
Is this research project open to adults aged 25 and older?
"This clinical trial necessitates that participants be aged between 50 and 85. There are 84 trials open to those below 18, while 918 studies are available for individuals older than 65 years of age."
Answered by AI
Can I join this clinical investigation?
"To be a viable applicant, those suffering from osteoarthritis of the knee must fall in the age range between 50 and 85. At present, 24 individuals are required to fill out this trial."
Answered by AI
What is the aggregate of participants enrolled in this research?
"Correct. Clinicaltrials.gov confirms that, since its initial posting on February 21st 2023, this trial is actively seeking participants with 24 individuals required from only one medical centre."
Answered by AI
Are any recruitment opportunities open for this trial currently?
"Affirmative. As per the information hosted on clinicaltrials.gov, this medical investigation is actively seeking participants and was last updated on 2/21/2023 after being initially posted that same day. 24 patients need to be enrolled from 1 location."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger