Efficacy and Safety of a Subcutaneous Tanezumab Titration Dosing Regimen in Subjects With Moderate to Severe Osteoarthritis of the Hip or Knee.

  • STATUS
    Recruiting
  • sponsor
    Pfizer
Updated on 23 November 2020

Summary

Efficacy and Safety of a Subcutaneous Tanezumab Titration Dosing Regimen in Subjects With Moderate to Severe Osteoarthritis of the Hip or Knee.

Description

The purpose of this study is to evaluate the safety and effectiveness of a new experimental medication for the treatment of moderate to severe osteoarthritis of the hip or knee.

Study medication and the cost for all study-related exams, tests and procedures will be provided at no cost to you or your insurance company. Compensation will be provided for reasonable time and travel-related costs.

Details
Clinical Study IdentifierTX146497
SponsorPfizer
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of Osteoarthritis of the knee or hip confirmed by X-ray
Documented history that subject tried the following medications and had insufficient pain relief or icannot take or tolerate them: acetaminophen, NSAIDs and either tramadol or opioids
Meet the protocol requirements for pain at screening and pain, physical function and patient global assessment of osteoarthritis at baseline
Willing to discontinue all pain medications except study medication and rescue medication during the course of the study and use those as directed per protocol
Women able to have children must agree to use 2 forms of contraception during the study

Exclusion Criteria

Body Mass Index (BMI) greater than 39
History of diseases other than osteoarthritis in a shoulder, hip or knee (example, rheumatoid arthritis, gout, joint infections, osteonecrosis)
Patients with x-ray showing joint conditions such as osteonecrosis (dead bone) or certain types of fractures
Patients who have had significant trauma or surgery to a knee, hip or shoulder within the previous year
Planned surgical procedure during the study
Patients who are largely or wholly incapacitated (for example, bedridden or confined to a wheelchair, permitting little or no self-care)
Patients who would be unwilling or unable to undergo joint replacement surgery, if one eventually became necessary
Patients with significant conditions other than osteoarthritis that could interfere with assessment of pain in the joints (example fibromyalgia, lupus erythematosus)
Patients with significant heart, neurological or psychiatric diseases
Patients who had cancer other than certain skin cancers within the past 5 years
Patients with alcohol, analgesic (pain medications) or drug abuse within the past 2 years
Women who are pregnant, breast-feeding or intending to become pregnant or breast-feed during the course of the study
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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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