A Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Study Of Study Medicine On Peripheral Nerve Function In Patients With Osteoarthritis

  • STATUS
    Recruiting
Updated on 8 November 2020

Summary

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Study Of Study Medicine On Peripheral Nerve Function In Patients With Osteoarthritis

Description

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Study Of Study Medicine On Peripheral Nerve Function In Patients With Osteoarthritis

Patient Inclusion Criteria:

  • BMI less or equal to 39 kg/m2
  • Osteoarthritis (arthritis) of the knee or hip with pain score that qualifies

Patient Exclusion Criteria:

  • Untreated, uncontrolled diseases,
  • Unwilling or unable to discontinue the use of prohibited medications, including other pain medications, during the screening period and during the study,
  • Significant cardiac disease within the past 6 months
  • Significant neurological disease
  • Known bleeding disorder or anticoagulation therapy
  • Planned surgery during the study period
  • History of alcoholism or drug abuse in the past 2 years
  • Unable to use acetaminophen
  • Use of a biologic (including live vaccines, with the exception of Flumist) within the past 3 months
  • Allergic reaction to a biologic or an antibody in the past
  • Disqualifying laboratory values, including Hepatitis B or C, HIV or drug test
  • Cancer in the past 5 years. Basal cell or squamous cell carcinoma are okay.

Details
Clinical Study IdentifierTX134905
Last Modified on8 November 2020

Eligibility

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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