Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex... | NCT00664560

NCT00664560

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
PN 400 (VIMOVO)	Drug	500 mg naproxen/20 mg esomeprazole bid	ARM 1 PN 400 (VIMOVO)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
American Pain Society Patient Outcome Questionnaire (APS-POQ)Total Interference Caused by Pain.	Mean change from Baseline scores calculated for each subject through Day 7. Scale 0 through 70, where 0=no pain interference and 70=complete interference.	Baseline and Day 7
Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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
Subjects who had started physical therapy on the index joint less than 6 weeks prior to study Screening
Use of any excluded concomitant medication
A recent history (in the past 3 months) suggestive of alcohol or drug abuse or dependence, including overuse/abuse of narcotics for management of pain
Serious blood coagulation disorder including use of systemic anti-coagulants
Screening laboratory value for alanine aminotransferase, aspartate aminotransferase greater than 2 times the upper limit of normal
Estimated creatinine clearance less than 30 ml/min
Other than noted specifically, any Screening laboratory value that was clinically significant in the investigator's opinion and would have endangered a subject if the subjects were to participate in the study
History of malignancy, treated or untreated, within the past 5 years, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin
Previous participation in another PN 400 clinical research trial
Subjects who were employees of the research facility or who were in some way under the supervision of the principal investigator for this study

Name	Affiliation	Role
Everardus Orlemans, PhD	POZEN	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
POZEN		Chapel Hill	North Carolina	27517	United States

PubMed Identifier	Type	Citation	Retractions
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 Jul;43(3):200-12. doi: 10.1080/00913847.2015.1074852. Epub 2015 Aug 3.
26235613	Derived

ID	Title	Description
FG000	(PN 400 (VIMOVO) Twice Daily)	PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
FG001	(Celebrex 200 mg Once Daily)	Celecoxib 200 mg (Celebrex) taken once daily
FG002	(Placebo Twice Daily)	placebo (sugar pill) dosed twice daily (bid)

ID	Title	Description
BG000	(PN 400 (VIMOVO) Twice Daily)	PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
BG001	(Celebrex 200 mg Once Daily)	Celecoxib 200 mg (Celebrex) taken once daily

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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).

Analysis Population: Baseline + took >= 1 dose + >= 1 post-baseline WOMAC efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward

Posted

Mean

Standard Deviation

Baseline and 12 weeks

ID	Title	Description
OG000	(PN 400 (VIMOVO) Twice Daily)

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	(PN 400 (VIMOVO) Twice Daily)	PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals