Expired Study
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Pompano Beach, Florida 33069


Purpose:

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


Criteria:

Inclusion Criteria: - Male or non-pregnant female subjects ≥ 50 years of age with history of OA of the knee as well as other standard inclusion criteria for a study of this nature Exclusion Criteria: - Standard exclusion criteria for a study of this nature


Study is Available At:


Original ID:

PN400-309


NCT ID:

NCT00665431


Secondary ID:


Study Acronym:


Brief Title:

Study Evaluating the Efficacy of PN 400 BID and Celecoxib QD in Patients With Osteoarthritis of the Knee


Official Title:

Randomized, Double-Blind, Parallel Group, Placebo-Controlled Multi-Center Study Evaluating the Efficacy of PN 400 BID and Celecoxib QD in Patients With Osteoarthritis of the Knee


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

50 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

POZEN


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

N/A


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Study Dates

Start Date:April 2008
Completion Date:January 2009
Completion Type:Actual
Primary Completion Date:December 2008
Primary Completion Type:Actual
Verification Date:December 2009
Last Changed Date:December 2, 2009
First Received Date:April 18, 2008

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:PN 400
Arm Name:1
Intervention Type:Drug
Name:celebrex
Arm Name:2
Intervention Type:Drug
Name:Placebo
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:1
Study Arm Type:Active Comparator
Arm Name:2
Study Arm Type:Placebo Comparator
Arm Name:3

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:POZEN

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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