You are here

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

Last updated on April 25, 2019

FOR MORE INFORMATION
Study Location
Alabama Orthopaedic Surgeons
Birmingham, Alabama, 35235 United States
Contact
877-355-2010
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Knee Osteoarthritis, Hip Osteoarthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 is cannot 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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 (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.

Trial Details
Administration
The form in which the study drug will be delivered to the patient's body.
Subcutaneous injections
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
Yes only
Trial Procedures
Physical examination
Vital signs and measurements
X-rays
Electrocardiogram (ECG)
Blood test
Keeping a diary
Questionnaire
NCT02697773
Pfizer
Completed
Efficacy and Safety of a Subcutaneous Tanezumab Titration Dosing Regimen in Subjects With Moderate to Severe Osteoarthritis of the Hip or Knee

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now