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Trial record 1 of 1 for:    NCT00366262
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Study Evaluating the Gastrointestinal Safety of PLA-695 Compared to Placebo and Naproxen

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ClinicalTrials.gov Identifier: NCT00366262
Recruitment Status : Completed
First Posted : August 21, 2006
Last Update Posted : August 5, 2008
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE August 17, 2006
First Posted Date  ICMJE August 21, 2006
Last Update Posted Date August 5, 2008
Study Start Date  ICMJE June 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August¬†18,¬†2006)
The rate of erosions and ulcers present after 7 days of treatment for PLA-65 will be compared to placebo and naproxen.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00366262 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating the Gastrointestinal Safety of PLA-695 Compared to Placebo and Naproxen
Official Title  ICMJE A Randomized, Double-Blind, Parallel Group Study To Compare The 7-Day Gastrointestinal Safety of 2 Doses of PLA-695 To That Of Placebo And Naproxen
Brief Summary The purpose of this study is to provide an initial assessment of the gastrointestinal safety of a 7-day regimen of PLA-695 compared to placebo or naproxen.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PLA-695
  • Drug: Naproxen
  • Drug: Placebo
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy men or women of nonchildbearing potential, aged 18 to 60 years.

Exclusion Criteria:

  • Abnormal baseline endoscopy.
  • Positive Helicobacter pylori serology.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00366262
Other Study ID Numbers  ICMJE 3175A1-103
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date August 2008

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