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NCT03098563

Maximizing Analgesia to Reduce Pain in Knee Osteoarthritis

Completed Phase 2 Results posted Last updated 11 December 2024
What this trial tests

Phase 2 trial testing Blinded study medication in Knee Osteoarthritis in 58 participants. Completed in 27 November 2023.

Timeline
1 November 2017
Primary endpoint
17 November 2023
27 November 2023

Quick facts

Lead sponsorJohns Hopkins University
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingtriple
Primary purposebasic science
Enrollment58
Start date1 November 2017
Primary completion17 November 2023
Estimated completion27 November 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Johns Hopkins University

Who can join

45 and older, any sex, with Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Largest Change From Baseline on Clinical Pain Rating Primary · 8 hour study session

The study will measure whether blinded study medications change clinical pain ratings (0-100 pain rating scale). Higher score indicates worse outcome. Biggest difference from baseline over the entire session is reported.

Baseline
GroupValue95% CI
Placebo + Placebo24.19± 23.63
Hydromorphone + Placebo30.48± 27.39
Dronabinol + Placebo28.55± 26.78
Hydromorphone + Dronabinol26.38± 25.86
Peak Effect
GroupValue95% CI
Placebo + Placebo12.76± 17.81
Hydromorphone + Placebo9.40± 16.27
Dronabinol + Placebo12.80± 17.50
Hydromorphone + Dronabinol12.41± 16.92

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 40 hours. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo + Placebo
Serious: 0/58 (0%)
Deaths: 0/58
Hydromorphone + Placebo
Serious: 0/58 (0%)
Deaths: 0/58
Dronabinol + Placebo
Serious: 0/58 (0%)
Deaths: 0/58
Hydromorphone + Dronabinol
Serious: 0/58 (0%)
Deaths: 0/58
Other adverse events (24 terms — click to expand)

ReactionSystemPlacebo + PlaceboHydromorphone + PlaceboDronabinol + PlaceboHydromorphone + Dronabinol
NauseaGastrointestinal disorders
Blurred VisionNervous system disorders
Dry MouthNervous system disorders
Light HeadedNervous system disorders
RestlessNervous system disorders
ChillsBlood and lymphatic system disorders
HeadacheBlood and lymphatic system disorders
HypotensiveCardiac disorders
Abdominal CrampsGastrointestinal disorders
DiarrheaGastrointestinal disorders
VomitingGastrointestinal disorders
ClumsyNervous system disorders
ConfusionNervous system disorders
CoughingNervous system disorders
DiaphoresisNervous system disorders
Difficulty ConcentratingNervous system disorders
DizzinessNervous system disorders
DrowsinessNervous system disorders
ImpairedNervous system disorders
Itchy EyesNervous system disorders
NumbNervous system disorders
TremorNervous system disorders
ParanoiaPsychiatric disorders
IncontenanceRenal and urinary disorders

Data from ClinicalTrials.gov NCT03098563 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Within-subject, double-blind, randomized, placebo-controlled evaluation of combining the cannabinoid dronabinol and the opioid hydromorphone in adults with chronic pain.
    Campbell CM, Mun CJ, Hamilton KR, Bergeria CL, et al · · 2023 · cited 6× · PMID 37202479 · DOI 10.1038/s41386-023-01597-1
  2. G Protein-Coupled Receptors in Osteoarthritis.
    Wang F, Liu M, Wang N, Luo J. · · 2021 · cited 4× · PMID 35154008 · DOI 10.3389/fendo.2021.808835
  3. Influence of the Synthetic Cannabinoid Agonist on Normal and Inflamed Cartilage: An In Vitro Study.
    Shang J, Hines S, Makarczyk MJ, Lin H, et al · · 2023 · cited 1× · PMID 37892184 · DOI 10.3390/biom13101502
  4. Evaluating the Acute Effects of the Cannabinoid Dronabinol and the Opioid Hydromorphone Alone and in Combination: A Double-blind, Randomized, Placebo-controlled Trial in Knee Osteoarthritis.
    Hamilton KR, Mun CJ, Sadik E, Bergeria CL, et al · · 2026 · PMID 41481837 · DOI 10.1097/aln.0000000000005925

Verify or expand the search:

Other recruiting trials for Knee Osteoarthritis

Currently open trials in the same condition.

Other Johns Hopkins University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03098563.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing