Phase 2 Completed N=58 Randomized Triple-blind Basic Science

Maximizing Analgesia to Reduce Pain in Knee Osteoarthritis

Source: ClinicalTrials.gov NCT03098563 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2024

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

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.

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

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. Informational only — not medical advice.