Back to resultsMeasuring Gait And Self-Reported Pain In Patients With Osteoarthritis Of The Knee Using Placebo/Oxycodone/Celecoxib.
Primary Purpose
Osteoarthritis
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
celecoxib
Oxycodone
placebo
Sponsored by
About this trial
This is an interventional other trial for Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Subject has been taking an NSAID at least 15 of the past 30 days for index knee pain
- Grades 2 or 3 OA as defined by the Kellgren and Lawrence Grading System of the medial tibiofemoral joint (joint space narrowing in the medial compartment > lateral compartment as assessed by x-ray) using the Altman Atlas of OA7. This must be documented with a report from an x-ray of the study joint taken either at screening or within 1 year prior to screening
- Subject meets American College of Rheumatology (ACR) clinical classification criteria for osteoarthritis of the knee, defined by the following: Knee pain and at least 3 of the following: oAge >50 oMorning stiffness <30 minutes oCrepitus on active motion oBony tenderness oBony enlargement oNo palpable warmth of synovium.
Exclusion Criteria:
- Subject has a documented history of an allergic reaction (hives, rash, etc.) or a clinically significant intolerance to celecoxib, sulfonamides, aspirin, or opioids including oxycodone
- Significant pain outside the index knee, including significant hip or back pain that can not be distinguished from OA pain or that interferes with ability to walk. (Patients with bilateral knee OA will be allowed into the study. The index knee should be defined as the more painful knee
- Predominantly patellofemoral knee osteoarthritis in the index knee as assessed by clinical examination
- Subject who are unable to discontinue all formulations of prior analgesics other than acetaminophen during the Washout Period of the study, or who are anticipated to be unable to discontinue rescue medication for 24 hours prior to the respective visits. (Low dose aspirin may be taken for cardiac prophylaxis
- Excessive signal knee joint laxity indicative of functional ligamentous deficiency
Sites / Locations
- VAPAHCS
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
A
B
C
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline in Knee Pain Intensity Measured by Numeric Rating Scale (NRS) at Week 12
The severity of arthritis pain in participant's signal knee at the time of the visit was assessed using an 11-point NRS, ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate worse pain.
Change From Baseline in Knee Pain Intensity Measured by Visual Analog Scale (VAS) at Week 12
The severity of arthritis pain in participant's signal knee was assessed using a 100-millimeter (mm) VAS ranging from 0 mm = no pain and 100 mm = most severe pain. Higher score indicate more pain.
Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Pain Subscale Score at Week 12
WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA of the hip and/or knee). The index consists of 24 questions (5 pain, 2 stiffness, and 17 physical function). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of to be replaced/replaced index joint (knee or hip) during past 48 hours. The WOMAC pain subscale score for each question ranges from 0 (minimum) to 4 (maximum), higher scores signifies worse pain. Pain subscale total score ranges from 0 to 20, with higher scores indicating worse pain.
Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Physical Function Subscale Score at Week 12
WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA of the hip and/or knee). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in in the study joint during past 48 hours. The WOMAC physical function subscale score for each question ranges from 0 (minimum) to 4 (maximum), higher scores signifies worse physical function. Physical function subscale scores range from 0 to 68, where higher scores indicated more difficulty in performing daily activities.
Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Stiffness Subscale Score at Week 12
WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA of the hip and/or knee). Stiffness was defined as a sensation of decreased ease of movement in study joint. The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the in the study joint during the past 48 hours. The WOMAC stiffness subscale score for each question ranges from 0 (minimum) to 4 (maximum), higher scores signifies worse stiffness. The stiffness subscale score ranges from 0 to 8, where higher scores indicated worse stiffness.
Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Total Score at Week 12
WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA of the hip and/or knee). The WOMAC composite index was the sum of 24 individual questions regarding subscales of pain, stiffness and physical function (for each item score range: 0 [minimum] to 4 [maximum], higher score indicating worse study joint condition). Total score was sum of the 3 subscale scores, giving a possible overall score range of 0 (minimum) to 96 (maximum). Higher score indicating the worse level of pain, stiffness and physical function.
Change From Baseline in Knee Adduction Moment at Week 12
Adduction (external) moment was defined as the ground-generated torque that forces the distal tibia toward the midline of the body, which forces the knee away from the midline, into a varus or "bow-legged" position. External knee adduction moment was assessed as percent body weight*height (%BW*ht).
Change From Baseline in Quadriceps Inhibition at Week 12
Quadriceps inhibition was assessed in terms of flexion-extension range of motion and normalized mid stance knee flexion angle in degrees.
Change From Baseline in Peak Ground Reaction Force at Week 12
Change from baseline in peak ground reaction force in body weight*seconds (BW*sec) was assessed with the help of a multicomponent force plate.
Change From Baseline in Total Ground Reaction Force at Week 12
Change from baseline in total ground reaction force in body weight*seconds was assessed with the help of a multicomponent force plate.
Change From Baseline in Stride Length at Week 12
The level walking was assessed by stride length; assessment was done based on 6 stride cycles over a range of walking speeds.
Change From Baseline in Walking Speed at Week 12
Change from baseline in walking speed in meters per second was assessed.
Change From Baseline in Cadence at Week 12
Cadence was defined as the rate at which a person walk, expressed in steps per minute.
Change From Baseline in Patient Global Assessment of Arthritic Condition (PGAAC) Score at Week 12
The PGAAC is self-administered measure in which participants answered the following question: "considering all the ways the OA in your signal knee affects you, how are you doing today?". Participants rated their condition using the following scale: 1= very good (no symptoms and no limitation of normal activities); 2= good (mild symptoms and no limitation of normal activities); 3= fair (moderate symptoms and limitation of some normal activities); 4= poor (severe symptoms and inability to carry out most normal activities); 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00484718
Brief Title
Measuring Gait And Self-Reported Pain In Patients With Osteoarthritis Of The Knee Using Placebo/Oxycodone/Celecoxib.
Official Title
MEASURES OF GAIT AND SELF-REPORTED PAIN IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE: A RANDOMIZED, SINGLE-BLIND WASHOUT, DOUBLE-BLIND TREATMENT, DOUBLE DUMMY CROSS-OVER PILOT TRIAL USING PLACEBO, OXYCODONE AND CELECOXIB (A9011030)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
January 17, 2008 (Actual)
Primary Completion Date
June 10, 2009 (Actual)
Study Completion Date
June 10, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Purpose of this trial is to evaluate the use of a cross-over trial design in an osteoarthritis population. We will determine the inter- and intra-subject variability in osteoarthritis (OA) endpoints and evaluate if efficacy can be detected by measuring OA endpoints following treatment with 2 different types of analgesics in a crossover study of this design.
Detailed Description
Methodology study to evaluate the use of a cross over design and gait analysis. The study was terminated by mutual consent with the study site at a meeting on the 1 April 2009, because of slow recruitment due to a high screen fail rate. The study was not stopped for safety reasons.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Active Comparator
Arm Title
C
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
celecoxib
Intervention Description
oral, 100 mg bid
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
oral, 20 mg bid
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral bid
Primary Outcome Measure Information:
Title
Change From Baseline in Knee Pain Intensity Measured by Numeric Rating Scale (NRS) at Week 12
Description
The severity of arthritis pain in participant's signal knee at the time of the visit was assessed using an 11-point NRS, ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate worse pain.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Knee Pain Intensity Measured by Visual Analog Scale (VAS) at Week 12
Description
The severity of arthritis pain in participant's signal knee was assessed using a 100-millimeter (mm) VAS ranging from 0 mm = no pain and 100 mm = most severe pain. Higher score indicate more pain.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Pain Subscale Score at Week 12
Description
WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA of the hip and/or knee). The index consists of 24 questions (5 pain, 2 stiffness, and 17 physical function). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of to be replaced/replaced index joint (knee or hip) during past 48 hours. The WOMAC pain subscale score for each question ranges from 0 (minimum) to 4 (maximum), higher scores signifies worse pain. Pain subscale total score ranges from 0 to 20, with higher scores indicating worse pain.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Physical Function Subscale Score at Week 12
Description
WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA of the hip and/or knee). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in in the study joint during past 48 hours. The WOMAC physical function subscale score for each question ranges from 0 (minimum) to 4 (maximum), higher scores signifies worse physical function. Physical function subscale scores range from 0 to 68, where higher scores indicated more difficulty in performing daily activities.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Stiffness Subscale Score at Week 12
Description
WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA of the hip and/or knee). Stiffness was defined as a sensation of decreased ease of movement in study joint. The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the in the study joint during the past 48 hours. The WOMAC stiffness subscale score for each question ranges from 0 (minimum) to 4 (maximum), higher scores signifies worse stiffness. The stiffness subscale score ranges from 0 to 8, where higher scores indicated worse stiffness.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Total Score at Week 12
Description
WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA of the hip and/or knee). The WOMAC composite index was the sum of 24 individual questions regarding subscales of pain, stiffness and physical function (for each item score range: 0 [minimum] to 4 [maximum], higher score indicating worse study joint condition). Total score was sum of the 3 subscale scores, giving a possible overall score range of 0 (minimum) to 96 (maximum). Higher score indicating the worse level of pain, stiffness and physical function.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Knee Adduction Moment at Week 12
Description
Adduction (external) moment was defined as the ground-generated torque that forces the distal tibia toward the midline of the body, which forces the knee away from the midline, into a varus or "bow-legged" position. External knee adduction moment was assessed as percent body weight*height (%BW*ht).
Time Frame
Baseline, Week 12
Title
Change From Baseline in Quadriceps Inhibition at Week 12
Description
Quadriceps inhibition was assessed in terms of flexion-extension range of motion and normalized mid stance knee flexion angle in degrees.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Peak Ground Reaction Force at Week 12
Description
Change from baseline in peak ground reaction force in body weight*seconds (BW*sec) was assessed with the help of a multicomponent force plate.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Total Ground Reaction Force at Week 12
Description
Change from baseline in total ground reaction force in body weight*seconds was assessed with the help of a multicomponent force plate.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Stride Length at Week 12
Description
The level walking was assessed by stride length; assessment was done based on 6 stride cycles over a range of walking speeds.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Walking Speed at Week 12
Description
Change from baseline in walking speed in meters per second was assessed.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Cadence at Week 12
Description
Cadence was defined as the rate at which a person walk, expressed in steps per minute.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Patient Global Assessment of Arthritic Condition (PGAAC) Score at Week 12
Description
The PGAAC is self-administered measure in which participants answered the following question: "considering all the ways the OA in your signal knee affects you, how are you doing today?". Participants rated their condition using the following scale: 1= very good (no symptoms and no limitation of normal activities); 2= good (mild symptoms and no limitation of normal activities); 3= fair (moderate symptoms and limitation of some normal activities); 4= poor (severe symptoms and inability to carry out most normal activities); 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition.
Time Frame
Baseline, Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has been taking an NSAID at least 15 of the past 30 days for index knee pain
Grades 2 or 3 OA as defined by the Kellgren and Lawrence Grading System of the medial tibiofemoral joint (joint space narrowing in the medial compartment > lateral compartment as assessed by x-ray) using the Altman Atlas of OA7. This must be documented with a report from an x-ray of the study joint taken either at screening or within 1 year prior to screening
Subject meets American College of Rheumatology (ACR) clinical classification criteria for osteoarthritis of the knee, defined by the following: Knee pain and at least 3 of the following: oAge >50 oMorning stiffness <30 minutes oCrepitus on active motion oBony tenderness oBony enlargement oNo palpable warmth of synovium.
Exclusion Criteria:
Subject has a documented history of an allergic reaction (hives, rash, etc.) or a clinically significant intolerance to celecoxib, sulfonamides, aspirin, or opioids including oxycodone
Significant pain outside the index knee, including significant hip or back pain that can not be distinguished from OA pain or that interferes with ability to walk. (Patients with bilateral knee OA will be allowed into the study. The index knee should be defined as the more painful knee
Predominantly patellofemoral knee osteoarthritis in the index knee as assessed by clinical examination
Subject who are unable to discontinue all formulations of prior analgesics other than acetaminophen during the Washout Period of the study, or who are anticipated to be unable to discontinue rescue medication for 24 hours prior to the respective visits. (Low dose aspirin may be taken for cardiac prophylaxis
Excessive signal knee joint laxity indicative of functional ligamentous deficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
VAPAHCS
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1290
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Citations:
PubMed Identifier
23508626
Citation
Asay JL, Boyer KA, Andriacchi TP. Repeatability of gait analysis for measuring knee osteoarthritis pain in patients with severe chronic pain. J Orthop Res. 2013 Jul;31(7):1007-12. doi: 10.1002/jor.22228. Epub 2013 Mar 18.
Results Reference
derived
PubMed Identifier
22179861
Citation
Boyer KA, Angst MS, Asay J, Giori NJ, Andriacchi TP. Sensitivity of gait parameters to the effects of anti-inflammatory and opioid treatments in knee osteoarthritis patients. J Orthop Res. 2012 Jul;30(7):1118-24. doi: 10.1002/jor.22037. Epub 2011 Dec 16.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9011030&StudyName=Measuring%20Gait%20And%20Self-Reported%20Pain%20In%20Patients%20With%20Osteoarthritis%20Of%20The%20Knee%20Using%20Placebo/Oxycodone/Celecoxib.
Description
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Measuring Gait And Self-Reported Pain In Patients With Osteoarthritis Of The Knee Using Placebo/Oxycodone/Celecoxib.
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