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

Phase 3

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: PN 400 (VIMOVO); Other: Placebo; Drug: celebrex; Drug: Rescue Antacid

• Registration Number: NCT00665431
• Lead Sponsor: POZEN

Brief Summary

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 Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-18
• Study First Submitted QC: 2008-04-22
• Study First Posted: 2008-04-23
• Primary Completion: 2008-12
• Study Completion: 2009-01
• Disposition First Submitted: 2009-12-02
• Disposition First Submitted QC: 2009-12-02
• Disposition First Posted: 2009-12-04
• Results First Submitted: 2010-05-27
• Status Verified: 2011-11
• Results First Submitted QC: 2011-11-01
• Last Update Submitted: 2011-11-01
• Results First Posted: 2011-12-06
• Last Update Posted: 2011-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 610

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1 PN 400 (VIMOVO)	Rescue Antacid	PN400: 500 mg naproxen/20 mg esomeprazole bid
Arm 1 PN 400 (VIMOVO)	PN 400 (VIMOVO)	PN400: 500 mg naproxen/20 mg esomeprazole bid
Arm 2 (Celebrex)	Rescue Antacid	Celecoxib 200 mg
Arm 3 (Placebo)	Placebo	sugar pill
Arm 3 (Placebo)	Rescue Antacid	sugar pill
Arm 2 (Celebrex)	celebrex	Celecoxib 200 mg

Primary Outcome Measures

Name	Time	Method
Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline	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	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.
Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline	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).

Secondary Outcome Measures

Name	Time	Method
Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline	Week 6	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).
Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline	Week 6	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	Week 6	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.
Mean Change From Baseline in American Pain Society Patient Outcome Questionnaire (APS-POQ)Total Interference Caused by Pain.	Baseline and Day 7	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.
Antacid Tablet Use	12 weeks	Tablet pill count
Percent of Days With no Heartburn (Heartburn Resolution)	12 weeks	During 12 weeks, daily heartburn question with ratings none, mild, moderate, or severe. Percent of days with Heartburn resolution (heartburn is none).
Modified Severity of Dyspepsia Assessment (mSODA)	12 weeks	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.
Number of Participants Reporting Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal (UGI) Symptoms	daily during 12 weeks	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.
The Number of Subjects Who Discontinued From the Study Due to Any Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal Adverse Event	daily during 12 weeks	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.

Trial Locations

Locations (1)

POZEN; 🇺🇸 Chapel Hill, North Carolina, United States