OsteoarthritisPhase 3NCT00665431

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

A Phase 3 study testing PN 400 (VIMOVO), celebrex and Rescue Antacid in people with Osteoarthritis, run by POZEN at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

We will evaluate the efficacy of PN 400 and an active comparator in patients that have Osteoarthritis of the knee. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Osteoarthritis
What is being tested?: PN 400 (VIMOVO), celebrex and Rescue Antacid
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 610 participants
Where: 1 siteUnited States
Study dates: Apr 2008to Jan 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 Current oral analgesic therapy was withdrawn at Screening.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.

Who cannot join

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

Show all 25Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

POZEN
Chapel Hill, North Carolina, 27517

Other trials in United States

About this study

Official title: Randomized, Double-Blind, Parallel Group, Placebo-Controlled Multi-Center Study Evaluating the Efficacy of PN400 (VIMOVO) Twice Daily (Bid) and Celecoxib Once Daily (qd) in Patients With Osteoarthritis of the Knee

We will evaluate the efficacy of PN 400 and an active comparator in patients that have Osteoarthritis of the knee.

Read the detailed description

3-Month study in subjects 50 years and older with osteoarthritis of the knee. Assessments Western Ontario and McMaster Universities (WOMAC) pain and function and patient global assessment scales.

Conditions: Osteoarthritis
Being tested: PN 400 (VIMOVO), celebrex, Placebo, Rescue Antacid
Medical subject headings: Osteoarthritis

What participants receive

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

PN 400 (VIMOVO)Drug
Also called PN400
500 mg naproxen/20 mg esomeprazole bid
celebrexDrug
200 mg celecoxib qd
PlaceboOther
sugar pill bid
Rescue AntacidDrug
Antacid Tablets

Study groups in NCT00665431
Study group	Role	What they receive
Arm 1 PN 400 (VIMOVO)	Experimental	PN400: 500 mg naproxen/20 mg esomeprazole bid Receives: Drug: PN 400 (VIMOVO); Drug: Rescue Antacid
Arm 2 (Celebrex)	Active comparator	Celecoxib 200 mg Receives: Drug: celebrex; Drug: Rescue Antacid
Arm 3 (Placebo)	Placebo comparator	sugar pill Receives: Other: Placebo; Drug: Rescue Antacid

What is being measured

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

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).
Measured: 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).
Measured: 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.
Measured: 12 Weeks

Secondary outcomes (9)

Mean Change From Baseline in American Pain Society Patient Outcome Questionnaire (APS-POQ)Total Interference Caused by Pain.
For APS-POQ score is the change from Baseline scores calculated for each subject through Day 7. Scale 0 through 70, where 0=no pain interference and 70=complete interference.
Measured: Baseline and Day 7
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 6 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).
Measured: Week 6
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).
Measured: Week 6
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.
Measured: Week 6
Antacid Tablet Use
Tablet pill count
Measured: 12 weeks
Modified Severity of Dyspepsia Assessment (mSODA)
Change from Baseline in the Modified Severity of Dyspepsia Assessment (mSODA) average daily pain intensity converted total score at Week 12. The mSODA instruments consists of 6 questions about abdominal discomfort during the past 24 hours, with a converted score of 2 through 47. Lower score equals less pain.
Measured: 12 weeks
Percent of Days With no Heartburn (Heartburn Resolution)
During 12 weeks, daily heartburn question with ratings none, mild, moderate, or severe. Percent of days with Heartburn resolution (heartburn is none).
Measured: 12 weeks
Number of Participants Reporting Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal (UGI) Symptoms
Number of participants reporting pre-specified non-steroidal antiinflammatory drug-associated (NSAID) upper gastrointestinal (UGI) symptoms. Pre-specified NSAID-associated UGI symptoms include adverse events such as dyspepsia, abdominal pain or discomfort, nausea, vomiting.
Measured: daily during 12 weeks
The Number of Subjects Who Discontinued From the Study Due to Any Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal Adverse Event
The number of subjects who discontinued from the study due to any pre-specified non-steroidal antiinflammatory drug (NSAID)-associated upper gastrointestinal (UGI) adverse event (as classified by MedDRA). Pre-specified NSAID-associated UGI symptoms include adverse events such as dyspepsia, abdominal pain or discomfort, nausea, vomiting.
Measured: daily during 12 weeks

Timeline

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

Apr 2008Jan 2009

First posted23 Apr 2008 (estimated)
Study startApr 2008
Primary completionDec 2008
Study completionJan 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 610 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00665431
Sponsor's protocol ID: PN400-309
Status last verified: Nov 2011
First submitted: 18 Apr 2008
Last updated: 6 Dec 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 26313454
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.
PubMed 26235613
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.
PubMed 21524238

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-Blind, Parallel Group, Placebo-Controlled Multi-Center Study Evaluating the Efficacy of PN400 (VIMOVO) Twice Daily (Bid) and Celecoxib Once Daily (qd) in Patients With Osteoarthritis of the Knee
ClinicalTrials.gov ID: NCT00665431
Acronym / sponsor ID: PN400-309
Conditions: Osteoarthritis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 610 participants (actual)
Lead sponsor: POZENIndustry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: Dec 2008 (actual)
Study completion: Jan 2009 (actual)
First posted: 23 Apr 2008 (estimated)
Results: Posted 6 Dec 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

We will evaluate the efficacy of PN 400 and an active comparator in patients that have Osteoarthritis of the knee.

Detailed description

3-Month study in subjects 50 years and older with osteoarthritis of the knee. Assessments Western Ontario and McMaster Universities (WOMAC) pain and function and patient global assessment scales.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Arm 1 PN 400 (VIMOVO)	Experimental	Drug: PN 400 (VIMOVO), Drug: Rescue AntacidPN400: 500 mg naproxen/20 mg esomeprazole bid
Arm 2 (Celebrex)	Active comparator	Drug: celebrex, Drug: Rescue AntacidCelecoxib 200 mg
Arm 3 (Placebo)	Placebo comparator	Other: Placebo, Drug: Rescue Antacidsugar pill

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (25 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PN 400 (VIMOVO)Also: PN400500 mg naproxen/20 mg esomeprazole bid	Drug	Arm 1 PN 400 (VIMOVO)
celebrex200 mg celecoxib qd	Drug	Arm 2 (Celebrex)
Placebosugar pill bid	Other	Arm 3 (Placebo)
Rescue AntacidAntacid Tablets	Drug	Arm 1 PN 400 (VIMOVO), Arm 2 (Celebrex), Arm 3 (Placebo)

Primary outcome

Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline
Time frame: Baseline and 12 Weeks
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).
Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline
Time frame: 12 Weeks
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).
Change in Patient Global Assessment (PGA) Subscore From Baseline
Time frame: 12 Weeks
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.

9 secondary outcomes

Mean Change From Baseline in American Pain Society Patient Outcome Questionnaire (APS-POQ)Total Interference Caused by Pain.
Time frame: Baseline and Day 7
Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline
Time frame: Week 6
Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline
Time frame: Week 6
Change in Patient Global Assessment (PGA) Subscore From Baseline
Time frame: Week 6
Antacid Tablet Use
Time frame: 12 weeks
Modified Severity of Dyspepsia Assessment (mSODA)
Time frame: 12 weeks
Percent of Days With no Heartburn (Heartburn Resolution)
Time frame: 12 weeks
Number of Participants Reporting Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal (UGI) Symptoms
Time frame: daily during 12 weeks
The Number of Subjects Who Discontinued From the Study Due to Any Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal Adverse Event
Time frame: daily during 12 weeks

Results and safety

Results posted to the registry on 6 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
(PN 400 (VIMOVO) Twice Daily)	243	203
(Celebrex 200 mg Once Daily)	245	188
(Placebo Twice Daily)	122	98

Primary outcome: Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline

Time frame: Baseline and 12 Weeks. Mean (Standard Deviation). Unit: mm

Measure	(PN 400 (VIMOVO) Twice Daily) n = 213	(Celebrex 200 mg Once Daily) n = 220	(Placebo Twice Daily) n = 106
Value	-44.1 (27.5)	-43.6 (25.2)	-37.3 (26.1)

(PN 400 (VIMOVO) Twice Daily) vs (Celebrex 200 mg Once Daily): Mean Difference (Final Values): -1.3 (95% CI -5.94 to 3.34), ANCOVA

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

Primary outcome: Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline

Time frame: 12 Weeks. Mean (Standard Deviation). Unit: mm

Measure	(PN 400 (VIMOVO) Twice Daily) n = 213	(Celebrex 200 mg Once Daily) n = 220	(Placebo Twice Daily) n = 106
Value	-38.7 (27.2)	-37.7 (27.5)	-30.9 (28)

(PN 400 (VIMOVO) Twice Daily) vs (Celebrex 200 mg Once Daily): Mean Difference (Final Values): -2.11 (95% CI -6.82 to 2.60), ANCOVA

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

Primary outcome: Change in Patient Global Assessment (PGA) Subscore From Baseline

Time frame: 12 Weeks. Mean (Standard Deviation). Unit: mm

Measure	(PN 400 (VIMOVO) Twice Daily) n = 235	(Celebrex 200 mg Once Daily) n = 234	(Placebo Twice Daily) n = 115
Value	27.7 (34.8)	26.4 (30.3)	22.4 (31.3)

(PN 400 (VIMOVO) Twice Daily) vs (Celebrex 200 mg Once Daily): Mean Difference (Final Values): 3.45 (95% CI -1.41 to 8.31), ANCOVA

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

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: randomization - 28 days post last dose. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
(PN 400 (VIMOVO) Twice Daily)	3 of 243 (1.2%)	111 of 243 (45.7%)	Not reported
(Celebrex 200 mg Once Daily)	3 of 245 (1.2%)	107 of 245 (43.7%)	Not reported
(Placebo Twice Daily)	1 of 122 (0.8%)	53 of 122 (43.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26313454Holt 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.
Derived from this study: PubMed 26235613Holt 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.
Derived from this study: PubMed 21524238Hochberg 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Everardus Orlemans, PhD study chair

POZEN

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PN 400 (VIMOVO), celebrex and Rescue Antacid in people with Osteoarthritis, run by POZEN at 1 site in United States.

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

Who may be eligible to take part?

The sponsor lists 7 inclusion and 25 exclusion criteria. 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: finished, as of the sponsor's last update on 6 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline (time frame: Baseline and 12 Weeks). The study lists 3 primary outcomes in all. 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 NCT00665431, which also lists 3 linked publications.

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 6 Dec 2011.