Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis

NCT00664560 | Completed Phase 3 Results

• 1 other identifier: PN400-307
• Study Type: interventional
• Target: 614
• Locations: 1 country
• Sites: 1

Brief Summary

We will evaluate the efficacy of PN400 and an active comparator in patients that have Osteoarthritis of the knee.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (3)

• Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline

  Western Ontario and McMaster Universities (WOMAC) pain questionnaire has 5 questions on pain all use visual analog scale (VAS) of 100 mm, with 0 mm being "no pain" and 100 mm being "extreme pain". The outcome measures a change in WOMAC pain at 12 weeks from baseline (in mm). WOMAC is a self-administered, patient-reported health status questionnaire designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. It consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function).

  Baseline and 12 weeks

• Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline

  WOMAC function questionnaire (VAS). The 17 questions about function all use visual analog scale (VAS) of 100 mm; 0 mm being "no pain" and 100 mm being "extreme pain". The outcome measures a change in WOMAC pain from baseline (in mm). The Western Ontario and McMaster Universities (WOMAC) is a self-administered, patient-reported health status questionnaire that is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function).

  12 weeks

• Change in Patient Global Assessment (PGA) Subscore From Baseline

  PGA questionnaire. The patient global assessment (PGA) question asks about how the subject is doing considering his/her arthritis and is measured by a visual analog scale (VAS); 0 mm (very poor) 100 mm (excellent). The outcome measures a change from baseline PGA in mm.

  12 weeks

Secondary Outcomes (9)

• American Pain Society Patient Outcome Questionnaire (APS-POQ)Total Interference Caused by Pain.

  Baseline and Day 7

• Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline

  Week 6

• Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline

  Week 6

• Change in Patient Global Assessment (PGA) Subscore From Baseline

  Week 6

• Antacid Tablet Use

  12 weeks

Study Arms (3)

ARM 1 PN 400 (VIMOVO)

EXPERIMENTAL

PN400: 500 mg naproxen/20 mg esomeprazole

Drug: PN 400 (VIMOVO); Drug: Rescue Antacid

Arm 2 (celebrex)

ACTIVE COMPARATOR

Celecoxib 200 mg

Drug: celebrex; Drug: Rescue Antacid

Arm 3 (placebo)

PLACEBO COMPARATOR

sugar pill

Drug: Placebo; Drug: Rescue Antacid

Interventions

PN 400 (VIMOVO) DRUG

500 mg naproxen/20 mg esomeprazole bid

Also known as: PN 400

ARM 1 PN 400 (VIMOVO)

celebrex DRUG

200 mg celecoxib qd

Arm 2 (celebrex)

Placebo DRUG

sugar pill bid

Arm 3 (placebo)

Rescue Antacid DRUG

Antacid Tablets

ARM 1 PN 400 (VIMOVO); Arm 2 (celebrex); Arm 3 (placebo)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant female subjects50 years of age and older with a 6-month history of OA of the knee
• Female subjects were eligible for participation in the study if they were of non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or of childbearing potential, had a negative pregnancy test at Screening, and using adequate contraceptive methods.
• Subjects were required to have been on a stable dose of NSAIDs, COX-2 inhibitors or other oral analgesic therapy for at least 6 weeks and required to continue treatment for 12 weeks. Current oral analgesic therapy was withdrawn at Screening.
• Each subject was required to be able to understand and comply with study procedures required of a subject and was able and willing to provide written informed consent prior to any study procedures being performed.
• Subjects were required to agree to keep physical activity at a stable level throughout the study.
• Subjects were required to have symptomatic OA of the knee meeting American College of Rheumatology (ACR) criteria for clinical diagnosis of OA.
• Subjects were required to have an ACR functional class rating of I, II or III. In addition, subjects meet the requirements for OA flare at the Baseline/ Randomization Visit.

You may not qualify if:

• Subjects with rheumatoid arthritis or gout/pseudo-gout
• Subjects with fibromyalgia syndrome
• Acute joint trauma at the index joint within the 3 months prior to screen with active symptoms
• Previous (in the past 12 months) or anticipated need for surgical or invasive procedure performed on the index joint during the study
• Subject was currently taking or anticipated to take Coumadin®, warfarin, or lithium
• History of hypersensitivity to esomeprazole or to another PPI
• History of allergic reaction or intolerance to any NSAID (including aspirin) and/or subject had a history of NSAID-induced symptoms of asthma, rhinitis, and/or nasal polyps
• History of allergic reactions to sulfonamides
• Subjects with intra-articular or intramuscular corticosteroids or intra-articular hyaluronic acid injections within 8 weeks prior to randomization
• Participation in any study of an investigational treatment in the 4 weeks before Screening
• Presence of uncontrolled acute or chronic medical illness, e.g. morbid obesity, GI disorder, diabetes, active GI disease, chronic or acute renal or hepatic disorder, depression and/or infection, etc, that would endanger a subject if the subject were to participate in the study
• GI disorder (e.g., severe erosive esophagitis, Zollinger Ellison syndrome) or surgery leading to impaired drug absorption
• Peptic ulcer disease within 6 months prior to Screening
• Evidence of uncontrolled, or unstable cardio- or cerebrovascular disorder, which in the investigator's opinion would have endangered a subject if the subject were to participate in the study
• Schizophrenia or bipolar disorder

Sponsors & Collaborators

• POZEN: lead

Study Sites (1)

POZEN

Chapel Hill, North Carolina, 27517, United States

Location

Related Publications (3)

• Holt RJ, Fort JG, Grahn AY, Kent JD, Bello AE. Onset and durability of pain relief in knee osteoarthritis: Pooled results from two placebo trials of naproxen/esomeprazole combination and celecoxib. Phys Sportsmed. 2015 Jul;43(3):200-12. doi: 10.1080/00913847.2015.1074852. Epub 2015 Aug 3.

  PMID: 26313454 DERIVED

• Holt RJ, Fort JG, Grahn AY, Kent JD, Bello AE. Onset and durability of pain relief in knee osteoarthritis: pooled results from two placebo trials of naproxen/esomeprazole combination and celecoxib. Phys Sportsmed. 2015 Aug 3:1-13. Online ahead of print.

  PMID: 26235613 DERIVED

• Hochberg MC, Fort JG, Svensson O, Hwang C, Sostek M. Fixed-dose combination of enteric-coated naproxen and immediate-release esomeprazole has comparable efficacy to celecoxib for knee osteoarthritis: two randomized trials. Curr Med Res Opin. 2011 Jun;27(6):1243-53. doi: 10.1185/03007995.2011.580340. Epub 2011 Apr 28.

  PMID: 21524238 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Celecoxib

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

Results Point of Contact

• Title: Sr VP Clinical Research
• Organization: POZEN Inc

eorlemans@pozen.com

919-913-1030

Study Officials

• Everardus Orlemans, PhD

  POZEN

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 23, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2009
• Last Updated: February 27, 2012
• Results First Posted: February 27, 2012

Record last verified: 2012-01

Locations

US (1)