Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study Evaluating the Effect on Gastroduodenal Mucosa of PA32540, PA32540 and Celecoxib, and Aspirin With Celecoxib (PA32540-109)

This study has been completed.
Sponsor:
Information provided by:
POZEN
ClinicalTrials.gov Identifier:
NCT00700687
First received: June 4, 2008
Last updated: January 9, 2009
Last verified: January 2009

June 4, 2008
January 9, 2009
June 2008
July 2008   (final data collection date for primary outcome measure)
Lanza scores [ Time Frame: entire course of study ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00700687 on ClinicalTrials.gov Archive Site
safety of three treatments [ Time Frame: entrie course of study ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study Evaluating the Effect on Gastroduodenal Mucosa of PA32540, PA32540 and Celecoxib, and Aspirin With Celecoxib
Study Evaluating the Effect on Gastroduodenal Mucosa of PA32540, PA32540 and Celecoxib, and Aspirin With Celecoxib

We will evaluate the effect on the gastroduodenal mucosa from oral dosing of three different treatments

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
  • Drug: PA32540
    aspirin/omeprazole
  • Drug: PA32540 and celecoxib
    aspirin/omeprazole and celecoxib
  • Drug: aspirin and [NSAID]
    aspirin and [NSAID]
  • Experimental: 1
    PA32540
    Intervention: Drug: PA32540
  • Experimental: 2
    PA32540 and celecoxib
    Intervention: Drug: PA32540 and celecoxib
  • Active Comparator: 3
    aspirin and celecoxib
    Intervention: Drug: aspirin and [NSAID]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
July 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male or non-pregnant female subjects greater than or equal to 50 years as well as other standard inclusion criteria for a study of this nature

Exclusion Criteria:

  • Standard exclusion criteria for a study of this nature
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00700687
PA32540-109
No
Eric Orlemans, POZEN
POZEN
Not Provided
Not Provided
POZEN
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP