Measuring Gait And Self-Reported Pain In Patients With Osteoarthritis Of The Knee Using Placebo/Oxycodone/Celecoxib.

NCT00484718 | Terminated Phase 4 Results

• 1 other identifier: A9011030
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (14)

• 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.

  Baseline, Week 12

• 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.

  Baseline, Week 12

• 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.

  Baseline, Week 12

• 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.

  Baseline, Week 12

• 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.

  Baseline, Week 12

• 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.

  Baseline, Week 12

• 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).

  Baseline, Week 12

• 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.

  Baseline, Week 12

• 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.

  Baseline, Week 12

• 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.

  Baseline, Week 12

• 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.

  Baseline, Week 12

• Change From Baseline in Walking Speed at Week 12

  Change from baseline in walking speed in meters per second was assessed.

  Baseline, Week 12

• Change From Baseline in Cadence at Week 12

  Cadence was defined as the rate at which a person walk, expressed in steps per minute.

  Baseline, Week 12

• 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.

  Baseline, Week 12

Study Arms (3)

A

ACTIVE COMPARATOR

Drug: celecoxib

B

ACTIVE COMPARATOR

Drug: Oxycodone

C

PLACEBO COMPARATOR

Drug: placebo

Interventions

celecoxib DRUG

oral, 100 mg bid

A

Oxycodone DRUG

oral, 20 mg bid

B

placebo DRUG

oral bid

C

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

VAPAHCS

Palo Alto, California, 94304-1290, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (2)

• 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.

  PMID: 23508626 DERIVED

• 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.

  PMID: 22179861 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Osteoarthritis

Interventions

Celecoxib; Oxycodone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

No efficacy analysis were conducted, as this study was stopped due to a high screen failure rate before the planned enrollment required to carry out the pre-specified efficacy analysis.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2007
• First Posted: June 11, 2007
• Study Start: January 17, 2008
• Primary Completion: June 10, 2009
• Study Completion: June 10, 2009
• Last Updated: April 14, 2021
• Results First Posted: April 14, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)