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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 August 15, 2018

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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

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Efficacy and Safety of a Subcutaneous Tanezumab Titration Dosing Regimen in Subjects With Moderate to Severe Osteoarthritis of the Hip or Knee
A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study Of The Analgesic Efficacy And Safety Of A Dose Titration Regimen For The Subcutaneous Administration Of Tanezumab In Subjects With Osteoarthritis Of The Hip Or Knee
The primary purpose of this study is to evaluate the efficacy of a titration arm of tanezumab in which treatment is started at a lower dose (2.5 mg) and increased to a higher dose (5 mg) at Week 8, compared to giving 2 doses of tanezumab 2.5 mg or 2 doses of placebo. The study also evaluates the safety of the treatment regimens.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Osteoarthritis, Knee
  • Osteoarthritis, Hip
  • Other: Placebo
    Patient receives one dose of placebo to match tanezumab subcutaneously on Day 1 and one dose of placebo to match tanezumab subcutaneously at Week 8.
  • Biological: Tanezumab 2.5 mg
    Patient receives one dose of tanezumab 2.5 mg subcutaneously on Day 1 and one dose of tanezumab 2.5 mg subcutaneously at Week 8.
  • Biological: Tanezumab 2.5mg/5mg
    Patient receives one dose of tanezumab 2.5 mg subcutaneously on Day 1 and one dose of tanezumab 5 mg subcutaneously at Week 8.
    Other Name: Titration Arm
  • Placebo Comparator: Placebo
    placebo administered subcutaneously at day 0 and week 8
    Intervention: Other: Placebo
  • Experimental: Tanezumab 2.5 mg
    tanezumab 2.5 mg administered subcutaneously at day 0 and week 8
    Intervention: Biological: Tanezumab 2.5 mg
  • Experimental: Tanezumab 2.5mg/5mg
    tanezumab 2.5 mg administered subcutaneously at day 0 and tanezumab 5 mg administered subcutaneously at week 8
    Intervention: Biological: Tanezumab 2.5mg/5mg
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
690
May 15, 2018
January 23, 2018   (Final data collection date for primary outcome measure)

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 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:

  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Canada,   Puerto Rico,   United States
 
 
NCT02697773
A4091056
2013-002222-23 ( EudraCT Number )
OA TITRATION STUDY ( Other Identifier: Alias Study Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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