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CompletedPhase 2

Maximizing Analgesia to Reduce Pain in Knee Osteoarthritis

Key facts

Who runs it
Johns Hopkins University
Where
Baltimore, United StatesSee the site
Trial code
Status
Completed
Phase
Phase 2
People taking part
58 people enrolled
Started
1 Nov 2017
Ended
27 Nov 2023
Type of study
Interventional, 4 groups
Treatments tested
  • Blinded study medication
Record updated
11 December 2024

Who can take part

Age
45 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Pain other than Knee Osteoarthritis
  • Taking opioids for pain
  • Prescribed and taking gabapentinoid, Tricyclic Antidepressants (TCA), venlafaxine, duloxetine, stimulants or benzodiazepines

Where in United States

  • Johns HopkinsBaltimore, United StatesNo longer taking part

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • Arm 1Treatment being tested

    Blinded study medication. This is a within-subject study so all session procedures will be identical. The specific medications administered that study day will be the only change each session. Study days will last approximately 8 hours and will be conducted on an outpatient basis. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit.

    Treatment: Blinded study medication

  • Arm 2Treatment being tested

    Blinded study medication. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit.

    Treatment: Blinded study medication

  • Arm 3Treatment being tested

    Blinded study medication. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit.

    Treatment: Blinded study medication

  • Arm 4Treatment being tested

    Blinded study medication. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit.

    Treatment: Blinded study medication

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Maximizing Analgesia to Reduce Pain Sensitivity in Chronic Knee Osteoarthritis Pain Patients
Publications
Record updated
11 December 2024