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OsteoarthritisPhase 2NCT00396955

A Study Comparing 4 Dose Regimens of PLA-695, Naproxen, and Placebo In Subjects With Osteoarthritis Of The Knee

A Phase 2 study testing PLA-695 in people with Osteoarthritis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 83 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Objectives: Primary:To assess the efficacy and safety of PLA-695 in subjects with active osteoarthritis (OA) of the knee. Secondary:To determine the pharmacokinetics (PK) and pharmacodynamics (PD) of PLA-695 among dose levels. To assess health outcome measures. Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Osteoarthritis
What is being tested?
PLA-695
How many people
560 participants
Where
83 sitesin 10 countries
Study dates
Nov 2006to Nov 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria: The main inclusion criteria is listed below, additional inclusion criteria is in the protocol.

  • Men or women 50 to 75 years of age. Women must be of non-childbearing potential. Sexually active men who are not surgically sterile must agree and commit to use of barrier contraception during the study and for at least 12 weeks after the last dose of PLA.
  • Diagnosed with idiopathic OA of the knee for at least 3 months duration in accordance with [1986] American College of Rheumatology (ACR) clinical and radiographic criteria: knee pain, the presence of osteophytes, and any one of the following: age >50 years, crepitus, or morning stiffness <30 minutes.
  • Radiographic confirmation of OA at the target joint (weight-bearing anteroposterior and lateral views) within 1 year of screening.
  • Must be currently treated for OA with a stable daily dose of 1 NSAID, including COX-2 inhibitors, not exceeding the maximum recommended dose in the product label, and taken as prescribed by the physician, starting at least 4 weeks before the screening visit.

Exclusion Criteria: These are some of the main exclusion criteria for the the study. Additional exclusion are included in the protocol.

  • History of or suspected current esophageal or gastrointestinal bleeding, ulcers, obstruction, or perforation, or pancreatitis.
  • Grade 4 severity on the Kellgren-Lawrence Scale on the screening target knee radiograph.
  • Any significant cardiovascular, hematologic, blood dyscrasia, endocrine, respiratory, neurologic, psychiatric, metabolic, immunologic, infectious, hepatic, or renal condition that the investigator considers detrimental to the subject's participating in the study or that may prevent the successful completion of the study.
  • Any clinically significant laboratory abnormality.

Trial locations and contacts

83 sites in 10 countries.

83 sites in 10 countries

United States39 sites

  • Study site

    Baltimore, Maryland, 21224

  • Study site

    Charleston, South Carolina, 29406

  • Study site

    Charlotte, North Carolina, 28210

  • Study site

    Chicago, Illinois, 60611

  • Study site

    Dallas, Texas, 75231

  • Study site

    Dallas, Texas, 75235

  • Study site

    Delray Beach, Florida, 33484

  • Study site

    Dover, New Hampshire, 03820

  • Study site

    Duncansville, Pennsylvania, 16635

  • Study site

    Fall River, Massachusetts, 02720

  • Study site

    Fort Lauderdale, Florida, 33334

  • Study site

    Frederick, Maryland, 21702

  • Study site

    Huntsville, Alabama, 35801

  • Study site

    Idaho Falls, Idaho, 83401

  • Study site

    Kalamazoo, Michigan, 49048

  • Study site

    Las Vegas, Nevada

  • Study site

    Mamaroneck, New York, 10543

  • Study site

    Milwaukee, Wisconsin, 53226

  • Study site

    Ocala, Florida, 34474

  • Study site

    Palm Harbor, Florida, 34684

  • Study site

    Palo Alto, California, 94304

  • Study site

    Rancho Mirage, California, 92270

  • Study site

    Salt Lake City, Utah, 84107

  • Study site

    San Antonio, Texas, 78217

  • Study site

    Santa Maria, California, 93455

  • Study site

    Scottsdale, Arizona, 85251

  • Study site

    Seattle, Washington, 98166

  • Study site

    South Miami, Florida, 33143

  • Study site

    Spokane, Washington, 99204

  • Study site

    St Louis, Missouri, 63128

  • Study site

    Syracuse, New York, 13210

  • Study site

    Tacoma, Washington, 98405

  • Study site

    Tampa, Florida, 33614

  • Study site

    Tucson, Arizona, 85704

  • Study site

    Tucson, Arizona

  • Study site

    Upland, California, 91786

  • Study site

    West Reading, Pennsylvania, 19611

  • Study site

    Wichita, Kansas, 67208

  • Study site

    Willow Grove, Pennsylvania, 19090

Other trials in United States

Canada17 sites

  • Study site

    Coquitlam, British Columbia, V3K 3P4

  • Study site

    Hamilton, Ontario, L8M 1K7

  • Study site

    Kelowna, British Columbia, V1Y 3G8

  • Study site

    Kitchener, Ontario, N2M 5N6

  • Study site

    Langley, British Columbia

  • Study site

    London, Ontario, N6A 4V2

  • Study site

    Montreal, Quebec, H1L 6J5

  • Study site

    Montreal, Quebec, H1T 4B3

  • Study site

    Montreal, Quebec, H3Z 2Z3

  • Study site

    Ottawa, Ontario, K1H 1A2

  • Study site

    Penticton, British Columbia

  • Study site

    Pointe-Claire, Quebec, H9R 3J1

  • Study site

    Québec, Quebec, G1W 4R4

  • Study site

    Sarnia, Ontario, N7T 4X3

  • Study site

    Toronto, Ontario, M4N 3M5

  • Study site

    Trois-Rivières, Quebec, G8Z 1Y2

  • Study site

    Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

Hungary5 sites

  • Study site

    Békéscsaba, H-5600

  • Study site

    Budapest, H-1036

  • Study site

    Debrecen

  • Study site

    Kiskunhalas, H-6400

  • Study site

    Nyíregyháza

Other trials in Hungary

Poland5 sites

  • Study site

    Krakow, 30-119

  • Study site

    Krakow, 31-121

  • Study site

    Szczecin

  • Study site

    Warsaw, 02-637

  • Study site

    Wroclaw, 53-347

Other trials in Poland

Argentina4 sites

  • Study site

    Capital Federal, Buenos Aires, 1122

  • Study site

    Capital Federal, Buenos Aires, 1180

  • Study site

    Cordoba-Capital, Córdoba Province, 5000

  • Study site

    San Miguel de Tucumán, Tucumán Province, T4000AXL

Other trials in Argentina

Netherlands4 sites

  • Study site

    's-Hertogenbosch, 5233 VG

  • Study site

    Almere Stad, 1311 RL

  • Study site

    Geleen, 6160 BB

  • Study site

    Nijmegen, 6525 EC

Other trials in Netherlands

Spain4 sites

  • Study site

    A Coruña, 15006

  • Study site

    Guadalajara, 19002

  • Study site

    Madrid, 28046

  • Study site

    Seville, 41009

Other trials in Spain

Mexico3 sites

  • Study site

    Guadalajara, Jalisco, 44620

  • Study site

    Mexico City, 6700

  • Study site

    Monterrey, Nuevo León, 64020

Other trials in Mexico

Brazil1 site

  • Study site

    São Paulo, São Paulo, 04020-060

Other trials in Brazil

Hong Kong1 site

  • Study site

    Hong Kong

Other trials in Hong Kong

About this study

Official title: A Multicenter, Randomized, Double-Blind Comparison of 4 Dose Regimens of Pla-695, Naproxen, and Placebo Administered Daily for 6 Weeks in Subjects With Active Osteoarthritis of the Knee

Objectives: Primary:To assess the efficacy and safety of PLA-695 in subjects with active osteoarthritis (OA) of the knee.

Secondary:To determine the pharmacokinetics (PK) and pharmacodynamics (PD) of PLA-695 among dose levels. To assess health outcome measures. To assess the effect of PLA-695 on biomarkers related to clinical responses. To assess PLA-695 exposure-response relationship on PD, efficacy, and safety measures. To assess pharmacogenomics (PGX) analysis in OA.

Read the detailed description

This is a multi-center, randomized, double-blind, double-dummy, parallel, placebo- and positive-control (naproxen), dose-ranging study to assess the efficacy and safety of 3 oral doses of PLA-695 administered QD and 1 dose of PLA-695 administered BID for 6 weeks. Subjects will be randomized to 1 of 6 treatment groups: PLA-695 50 mg, 200 mg, or 400 mg QD, PLA-695 200 mg BID, placebo, or naproxen 500 mg BID. Subjects will undergo a washout period of 2 to 14 days. The number of days for washout will be determined by the pre-study NSAID of each subject. Subjects who washout from previous therapy with an increase in signs and symptoms of OA will be randomly assigned to receive PLA-695.

Conditions
Osteoarthritis
Being tested
PLA-695
Keywords
osteoarthritis, arthritis, pain
Medical subject headings
Osteoarthritis, Arthritis, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PLA-695Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. WOMAC VAS walking pain (question 1) at week 6 is the primary endpoint.

Secondary outcomes (1)

  1. WOMAC VAS walking pain at weeks 1, 2, 3, 4, and 5; WOMAC pain, stiffness, and function subscales, and composite score; Investigatorsâ Efficacy Evaluation; Investigatorsâ overall assessment; Joint tenderness. Subjectsâ Efficacy Evaluation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionNov 2007
  4. Study completionNov 2007

Why it stopped: imbalance of gastrointestinal and the lipase events

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
560 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00396955
Sponsor's protocol ID
3175A1-202
Status last verified
Dec 2007
First submitted
7 Nov 2006
Last updated
28 Dec 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PLA-695 in people with Osteoarthritis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 83 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States, Canada, Hungary, Poland, Argentina and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: imbalance of gastrointestinal and the lipase events). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

WOMAC VAS walking pain (question 1) at week 6 is the primary endpoint.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00396955.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2007.

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