Montelukast for Posttraumatic Osteoarthritis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UK Healthcare at Turfland, Lexington, KYPosttraumatic Osteoarthritis+2 MoreMontelukast - Drug
Eligibility
25 - 50
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether montelukast can reduce markers of inflammation and cartilage degradation in people who have undergone ACL reconstruction, specifically targeting those with additional meniscal injuries who are at greater risk of rapid cartilage degradation.

Eligible Conditions
  • Posttraumatic Osteoarthritis
  • Meniscus Tears
  • Anterior Cruciate Ligament Injury

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 0 Secondary · Reporting Duration: Change between Visit 4 (4 weeks post surgery) and Visit 6 (1 year post surgery)

Year 1
Knee injury and Osteoarthritis Outcome Score (KOOS)
Serum prostaglandin E2
Year 1
Magnetic Resonance Imaging
T1rho relaxation time on MRI

Trial Safety

Safety Progress

1 of 3

Side Effects for

Montelukast
16%Cold/Upper Respiratory Infection
10%Diarrhea
6%Vomiting
This histogram enumerates side effects from a completed 2005 Phase 4 trial (NCT00189462) in the Montelukast ARM group. Side effects include: Cold/Upper Respiratory Infection with 16%, Diarrhea with 10%, Vomiting with 6%.

Trial Design

2 Treatment Groups

Montelukast
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

30 Total Participants · 2 Treatment Groups

Primary Treatment: Montelukast · Has Placebo Group · Phase < 1

Montelukast
Drug
Experimental Group · 1 Intervention: Montelukast · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Montelukast
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: change between visit 4 (4 weeks post surgery) and visit 6 (1 year post surgery)

Who is running the clinical trial?

Austin V StoneLead Sponsor
4 Previous Clinical Trials
92 Total Patients Enrolled
Duke UniversityOTHER
2,207 Previous Clinical Trials
3,220,759 Total Patients Enrolled
University of California, San FranciscoOTHER
2,312 Previous Clinical Trials
11,758,296 Total Patients Enrolled
Cale Jacobs, PhDLead Sponsor
4 Previous Clinical Trials
228 Total Patients Enrolled
The Cleveland ClinicOTHER
959 Previous Clinical Trials
1,364,033 Total Patients Enrolled

Eligibility Criteria

Age 25 - 50 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are having surgery to reconstruct your ACL for the first time.
You have a knee injury affecting the meniscus at the same time.

Frequently Asked Questions

Are octogenarians permitted to partake in this clinical investigation?

"This clinical study is searching for qualified participants aged between 25 and 50 years old." - Anonymous Online Contributor

Unverified Answer

Who fulfills the eligibility criteria for this clinical trial?

"To qualify as a potential participant in this clinical trial, individuals must have been diagnosed with degenerative polyarthritis and be between 25 and 50 years old. The total capacity for the study is 30 patients." - Anonymous Online Contributor

Unverified Answer

What is the upper limit of participants in this clinical examination?

"Affirmative. Evidence from clinicaltrials.gov reveals that this medical trial, which initiated recruitment on February 1st 2021, is currently seeking volunteers to join the experiment. The research requires 30 participants based at a single site." - Anonymous Online Contributor

Unverified Answer

For what conditions is Montelukast usually prescribed?

"Montelukast is effective at managing exercise-induced bronchospasm, perennial allergic rhinitis (PAR), seasonal allergies and asthma." - Anonymous Online Contributor

Unverified Answer

To what other research studies has Montelukast been applied?

"Currently, there are 22 active clinical trials of montelukast with 6 of these studies in phase 3. Of the 221 trial sites across the globe, several have been established in Lexington, Kentucky." - Anonymous Online Contributor

Unverified Answer

Are recruitment efforts ongoing for this clinical trial?

"Confirmed, clinicaltrials.gov currently lists this trial as actively recruiting participants. The project was initially announced on February 1st 2021 and has been updated most recently on September 12th 2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.