Phase 2 N=58 Randomized Triple-blind Basic Science

Maximizing Analgesia to Reduce Pain in Knee Osteoarthritis

Knee Osteoarthritis

Bottom Line

View on ClinicalTrials.gov: NCT03098563 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2024

Primary outcome: Primary: Largest Change From Baseline on Clinical Pain Rating — 24.19; 30.48; 28.55; 26.38 score on a scale — p=.021

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Blinded study medication (Drug)
Age: Adult, Older Adult · 45+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Nov 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Largest Change From Baseline on Clinical Pain Rating	24.19; 30.48; 28.55; 26.38; 12.76; 9.40	.021 sig

Summary

This research is being done to evaluate whether combining medications that are FDA approved, but have not yet been approved for combination treatment, can be effective in reducing pain.

Eligibility Criteria

Inclusion Criteria

Diagnosis of knee osteoarthritis
Urine sample tests negative for common illicit substances of abuse (e.g., cannabis)
Medically cleared to take study medications
Are not pregnant or breast feeding
Willing to comply with the study protocol.

Exclusion Criteria

Pain other than Knee Osteoarthritis
Taking opioids for pain
Prescribed and taking gabapentinoid, Tricyclic Antidepressants (TCA), venlafaxine, duloxetine, stimulants or benzodiazepines
Presence of any clinically significant medical/psychiatric illness judged by the investigators to put subject at elevated risk for experiencing an adverse event
Known allergy to the blinded study medications

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03098563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.