A Study of ARRY-371797 in Patients With Osteoarthritis of the Knee

NCT01366014

Last updated date
Study Location
Pfizer Investigational Site
Phoenix, Arizona, , United States
Contact
1-800-718-1021

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis of the Knee
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of OA of the knee, based on American College of Rheumatology (ACR) criteria, confirmed by X-ray (K-L Grade II/III within the last year).

- At least moderate or severe pain due to OA in one knee.

- On nonsteroidal anti-inflammatory drug (NSAID) 28 days previous to study start and willing to continue on NSAID throughout study.

- Discontinuation of opioids prior to study start.

- Additional criteria exist.

Key

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Current or recent infection in the last 7 days; infection requiring hospitalization or
parenteral antibiotics within the last 6 months; history of or currently active
tuberculosis, hepatitis B or C, or human immunodeficiency virus (HIV).


- Surgery on the index knee within the previous 6 months.


- Trauma or other surgeries within the previous 8 weeks.


- Specific abnormal laboratory values or electrocardiogram abnormalities.


- Gastrointestinal surgery that may interfere with motility or absorption.


- On non-stable dose of bisphosphonates, or any prior denosumab or parathyroid hormone
(PTH) therapies.


- Prior parenteral tumor necrosis factor (TNF) inhibitor or anti-nerve growth factor
(NGF) therapies.


- Intramuscular, intravenous or oral corticosteroids within the previous 6 weeks.


- Intra-articular corticosteroids in the index knee within the previous 8 weeks or
viscosupplementation in the index knee within the previous 4 months.


- Currently enrolled in or participated in another clinical trial within the previous 3
months.


- Additional criteria exist.

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Osteoarthritis of the KneeA Study of ARRY-371797 in Patients With Osteoarthritis of the Knee
NCT01366014
  1. Phoenix, Arizona
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  7. Shenyang, Liaoning
  8. Jinan, Shandong
  9. Liaocheng, Shandong
  10. Qingdao, Shandong
  11. Qingdao, Shandong
  12. Xi'an, Shanxi
  13. Chengdu, Sichuan
  14. Chengdu, Sichuan
  15. Chengdu, Sichuan
  16. Chengdu, Sichuan
  17. Beijing,
  18. Beijing,
  19. Beijing,
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  23. Shanghai,
  24. Shanghai,
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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of ARRY-371797 in Patients With Osteoarthritis of the Knee
Official Title  ICMJE Not Provided
Brief Summary This is a Phase 2 study, involving a 4-week treatment period, designed to test the ability of investigational study drug ARRY-371797 to reduce pain in patients with moderate to severe pain due to osteoarthritis (OA) of the knee, and to further evaluate the drug's safety. Approximately 150 patients from the US will be enrolled in this study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis of the Knee
Intervention  ICMJE
  • Drug: ARRY-371797, p38 inhibitor; oral
    multiple dose, single schedule
  • Drug: Oxycodone hydrochloride (HCl) extended release (ER), opioid agonist; oral
    multiple dose, single schedule
  • Drug: Placebo; oral
    matching placebo
Study Arms  ICMJE
  • Experimental: ARRY-371797
    Intervention: Drug: ARRY-371797, p38 inhibitor; oral
  • Active Comparator: Oxycodone HCl ER
    Intervention: Drug: Oxycodone hydrochloride (HCl) extended release (ER), opioid agonist; oral
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo; oral
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2012)
157
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2011)
150
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Diagnosis of OA of the knee, based on American College of Rheumatology (ACR) criteria, confirmed by X-ray (K-L Grade II/III within the last year).
  • At least moderate or severe pain due to OA in one knee.
  • On nonsteroidal anti-inflammatory drug (NSAID) 28 days previous to study start and willing to continue on NSAID throughout study.
  • Discontinuation of opioids prior to study start.
  • Additional criteria exist.

Key Exclusion Criteria:

  • Current or recent infection in the last 7 days; infection requiring hospitalization or parenteral antibiotics within the last 6 months; history of or currently active tuberculosis, hepatitis B or C, or human immunodeficiency virus (HIV).
  • Surgery on the index knee within the previous 6 months.
  • Trauma or other surgeries within the previous 8 weeks.
  • Specific abnormal laboratory values or electrocardiogram abnormalities.
  • Gastrointestinal surgery that may interfere with motility or absorption.
  • On non-stable dose of bisphosphonates, or any prior denosumab or parathyroid hormone (PTH) therapies.
  • Prior parenteral tumor necrosis factor (TNF) inhibitor or anti-nerve growth factor (NGF) therapies.
  • Intramuscular, intravenous or oral corticosteroids within the previous 6 weeks.
  • Intra-articular corticosteroids in the index knee within the previous 8 weeks or viscosupplementation in the index knee within the previous 4 months.
  • Currently enrolled in or participated in another clinical trial within the previous 3 months.
  • Additional criteria exist.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01366014
Other Study ID Numbers  ICMJE ARRAY-797-223
C4411007 ( Other Identifier: Pfizer )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP