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NCT03878589: UCOPE

Understanding Cognition, Oxytocin & Pain in Elders

Completed Phase 2, PHASE3 Results posted Last updated 23 February 2026
What this trial tests

Phase 2, PHASE3 trial testing Oxytocin (OT) in Knee Osteoarthritis in 83 participants. Completed in 19 December 2024.

Timeline
6 August 2019
Primary endpoint
19 December 2024
19 December 2024

Quick facts

Lead sponsorUniversity of Florida
PhasePhase 2, PHASE3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingquadruple
Primary purposetreatment
Enrollment83
Start date6 August 2019
Primary completion19 December 2024
Estimated completion19 December 2024
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Florida

Who can join

Adults 45 to 100, any sex, with Knee Osteoarthritis or 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.

Change in WOMAC Pain (0-20 Scale) Primary · Baseline -> Week 4

The WOMAC Pain subscale measures self-reported knee pain severity during daily activities. The subscale consists of 5 items assessing pain during walking, stair climbing, nocturnal pain, pain at rest, and weight-bearing activities. Each item is scored 0-4 (0=none, 4=extreme), yielding a total Pain subscale score of 0-20. Higher scores indicate greater pain severity. Change scores were calculated as post-treatment minus baseline; negative values indicate improvement (reduced pain).

GroupValue95% CI
Oxytocin-0.14± 2.92
Placebo-0.65± 3.03

Adverse events — posted to ClinicalTrials.gov

Time frame: During each 4-week treatment period (8 weeks total across both crossover periods). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Oxytocin
Serious: 0/66 (0%)
Deaths: 0/66
Placebo
Serious: 3/68 (4%)
Deaths: 0/68

Serious adverse events (3 terms)

ReactionSystemOxytocinPlacebo
Autonomic dysfunction (vertigo, SOB, chest pain)Nervous system disorders
Upper respiratory infectionRespiratory, thoracic and mediastinal disorders
Diplopia and dizzinessNervous system disorders
Other adverse events (12 terms — click to expand)

ReactionSystemOxytocinPlacebo
Nasal symptoms (congestion, runny nose, irritation)Respiratory, thoracic and mediastinal disorders
Drowsiness/sleepinessNervous system disorders
FatigueGeneral disorders
Cough/sneezingRespiratory, thoracic and mediastinal disorders
Mood/anxiety changesPsychiatric disorders
HeadachesNervous system disorders
Throat symptoms (dry/sore throat, hoarseness)Respiratory, thoracic and mediastinal disorders
GI symptoms (constipation, diarrhea, nausea)Gastrointestinal disorders
Skin symptoms (rash, itching, tingling)Skin and subcutaneous tissue disorders
Cardiovascular (chest pain, BP changes, palpitations)Cardiac disorders
Light headedness/vertigoNervous system disorders
Urinary changesRenal and urinary disorders

Most-reported serious reactions: Autonomic dysfunction (vertigo, SOB, chest pain), Upper respiratory infection, Diplopia and dizziness.

Data from ClinicalTrials.gov NCT03878589 adverse events section.

Sponsor's own description

Osteoarthritis (OA) represents a significant cause of disability worldwide and the knee is the most commonly affected joint. Oxytocin (OT) is a mediator of endogenous analgesia in animal and human studies. This proposal will test the efficacy and safety of self-administered intranasal OT over 4-weeks in older individuals relative to placebo (P) evaluating its effects on pain and function in aging and testing potential underlying neurobiological mechanisms.

Publications & conference data

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

  1. Safety and tolerability of chronic intranasal oxytocin in older men: results from a randomized controlled trial.
    Rung JM, Horta M, Tammi EM, Perez E, et al · · 2021 · cited 16× · PMID 33982141 · DOI 10.1007/s00213-021-05862-3
  2. Pain and Nutrition in Dementia and Alzheimer's Phase 1: a cross-sectional, observational study design.
    Judkins TC, Andrews HJ, Song Q, Clark EI, et al · · 2026 · PMID 41988414 · DOI 10.3389/frdem.2026.1789761
  3. Understanding Cognition, Oxytocin, and Pain in Elders (UCOPE): protocol for a double-blinded cross-over trial in chronic knee osteoarthritis pain.
    Cruz-Almeida Y, Montesino-Goicolea S, Valdes-Hernandez P, Huo Z, et al · · 2025 · PMID 39920837 · DOI 10.1186/s13063-024-08715-4

Verify or expand the search:

Other recruiting trials for Knee Osteoarthritis

Currently open trials in the same condition.

Other University of Florida trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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