A Study Of The Safety And Efficacy Of PF-04191834 In Patients With Osteoarthritis Of The Knee

NCT01147458 | Terminated Phase 2 Results

• 1 other identifier: B0041007
• Study Type: interventional
• Target: 190
• Locations: 3 countries
• Sites: 31

Brief Summary

PF-04191834 works in animal models by inhibiting one of the enzymes, 5-lipoxygenasein which is involved in the pathway that causes inflammation and pain. The purpose of this study is to test how effective, safe and tolerated PF-04191834 is in patients with osteoarthritis of the knee by itself or with naproxen, particularly to test if patients have less pain.

Conditions

Osteoarthritis, Knee

Keywords

Cross-over; safety; efficacy; tolerability; osteoarthritis; knee; pain

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Western Ontario & McMaster (WOMAC) Osteoarthritis Index Pain Score at the End of Treatment Period 1

  The WOMAC Pain subscale, comprised of 5 questions regarding the amount of pain experienced in the index joint, was calculated as the mean of the scores from the 5 individual questions. The WOMAC Pain subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-20, with higher scores indicating higher pain.

  Baseline (Day 1 of Visit 3) and end of treatment Period 1 (Day 15+1 of Visit 5)

• Change From Baseline in Western Ontario & McMaster (WOMAC) Osteoarthritis Index Pain Score at the End of Treatment Period 2

  The WOMAC Pain subscale, comprised of 5 questions regarding the amount of pain experienced in the index joint, was calculated as the mean of the scores from the 5 individual questions. The WOMAC Pain subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-20, with higher scores indicating higher pain.

  Baseline (Day 28 of Visit 7) and end of treatment Period 2 (Day 43+1 of Visit 9)

Secondary Outcomes (9)

• WOMAC Stiffness Domain Score

  Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2

• WOMAC Physical Function Domain Score

  Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2

• WOMAC Total Score

  Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2

• Importance Weighted Total WOMAC Score

  Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2

• Daily Diary Pain Score During Week 1 of Each Treatment Period

  4 days prior to baseline visits (Visits 3 for Period 1 and Vist 8 for Period 2) up to 7 days after baseline visits

Study Arms (4)

PF-04191834 followed by placebo

EXPERIMENTAL

PF-04191834 600 mg BID dose followed by matched placebo plus naproxen placebo.

Drug: PF-04191834; Drug: PF-04191834 placebo; Drug: Naproxen placebo

Placebo followed by PF-04191834

EXPERIMENTAL

Placebo followed by 600 mg BID dose of PF-04191834 plus naproxen placebo.

Drug: PF-04191834 placebo; Drug: PF-04191834; Drug: Naproxen placebo

PF-04191834+Naproxen followed by Naproxen

EXPERIMENTAL

PF-04191834 600 mg BID + Naproxen 500 mg BID followed by Naproxen 500 mg BID plus PF-04191834 placebo

Drug: PF-04191834; Drug: Naproxen; Drug: PF-04191834 placebo

Naproxen followed by PF-04191834+Naproxen

EXPERIMENTAL

Naproxen 500 mg BID followed by PF-04191834 600 mg BID + Naproxen 500 mg BID

Drug: Naproxen; Drug: PF-04191834 placebo; Drug: PF-04191834

Interventions

PF-04191834 DRUG

100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks

PF-04191834 followed by placebo

PF-04191834 placebo DRUG

Matching PF-04191834 placebo tablets to be administered BID for two weeks

PF-04191834 followed by placebo

Naproxen placebo DRUG

Matching naproxen placebo tablets to be administered BID for 4 weeks

PF-04191834 followed by placebo

Naproxen DRUG

Naproxen 500 mg tablet administered BID for a total of four weeks

PF-04191834+Naproxen followed by Naproxen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have a diagnosis of osteoarthritis based on the American College of Rheumatology criteria confirmed by an X-ray
• Subjects must be willing and able to stop all current pain therapy for the duration of the study
• Subjects must be willing and able to complete a daily diary

You may not qualify if:

• BMI of \>39 kg/m2
• Known allergy or hypersensitivity to naproxen
• Any condition or medical history that might interfere with the subject's ability to complete the study visits and assessments

Sponsors & Collaborators

• Pfizer: lead

Study Sites (31)

Pfizer Investigational Site

Peoria, Arizona, 85381, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85013, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85015, United States

Location

Pfizer Investigational Site

Anaheim, California, 92801, United States

Location

Pfizer Investigational Site

Carmichael, California, 95608, United States

Location

Pfizer Investigational Site

Fair Oaks, California, 95628, United States

Location

Pfizer Investigational Site

San Diego, California, 92128, United States

Location

Pfizer Investigational Site

Denver, Colorado, 80209, United States

Location

Pfizer Investigational Site

DeLand, Florida, 32720, United States

Location

Pfizer Investigational Site

Pensacola, Florida, 32504, United States

Location

Pfizer Investigational Site

South Miami, Florida, 33143, United States

Location

Pfizer Investigational Site

South Bend, Indiana, 46601, United States

Location

Pfizer Investigational Site

Overland Park, Kansas, 66211, United States

Location

Pfizer Investigational Site

Overland Park, Kansas, 66212, United States

Location

Pfizer Investigational Site

Worcester, Massachusetts, 01610, United States

Location

Pfizer Investigational Site

Edina, Minnesota, 55435, United States

Location

Pfizer Investigational Site

Saint Paul, Minnesota, 55114, United States

Location

Pfizer Investigational Site

Las Vegas, Nevada, 89144, United States

Location

Pfizer Investigational Site

Monroe, North Carolina, 28112, United States

Location

Pfizer Investigational Site

Fargo, North Dakota, 58103, United States

Location

Pfizer Investigational Site

Columbus, Ohio, 43213, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19139, United States

Location

Pfizer Investigational Site

Austin, Texas, 78705, United States

Location

Pfizer Investigational Site

Arlington, Virginia, 22205, United States

Location

Pfizer Investigational Site

St. John's, Newfoundland and Labrador, A1A 3R5, Canada

Location

Pfizer Investigational Site

Québec, Quebec, G1V 3M7, Canada

Location

Pfizer Investigational Site

Québec, Quebec, G1W 4R4, Canada

Location

Pfizer Investigational Site

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

Pfizer Investigational Site

Gothenburg, 413 45, Sweden

Location

Pfizer Investigational Site

Stockholm, 115 22, Sweden

Location

Related Links

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

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Pain

Interventions

Naproxen

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Limitations and Caveats

The study was terminated early due to increases in hepatic enzymes for which a relationship to study drug could not be excluded and that could alter the potential benefit-risk for participants continuing in the study.

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2010
• First Posted: June 22, 2010
• Study Start: July 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: June 6, 2013
• Results First Posted: May 21, 2013

Record last verified: 2013-05

Locations

SE (2); US (25); CA (4)