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Prevention of Altitude Illness With Non-steroidal Anti-inflammatory Study (PAINS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01171794
First Posted: July 28, 2010
Last Update Posted: April 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Grant S Lipman, Stanford University
Results First Submitted: October 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Altitude Sickness
Interventions: Drug: Ibuprofen
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ibuprofen Ibuprofen : 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)
Placebo Visually identical placebo

Participant Flow:   Overall Study
    Ibuprofen   Placebo
STARTED   47   42 
COMPLETED   44   42 
NOT COMPLETED   3   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants meeting all inclusion criteria were analyzed

Reporting Groups
  Description
Ibuprofen Ibuprofen : 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)
Placebo Visually identical placebo
Total Total of all reporting groups

Baseline Measures
   Ibuprofen   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 44   42   86 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      44 100.0%      42 100.0%      86 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.4  (14.5)   34.2  (13.2)   36.6  (13.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      14  31.8%      14  33.3%      28  32.6% 
Male      30  68.2%      28  66.7%      58  67.4% 


  Outcome Measures
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1.  Primary:   Acute Mountain Sickness   [ Time Frame: 2 days ]

2.  Primary:   Acute Mountain Sickness Severity   [ Time Frame: 2 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Grant S Lipman ( PI)
Organization: Stanford University School of Medicine
phone: 4152909286
e-mail: lipmangrant@gmail.com



Responsible Party: Grant S Lipman, Stanford University
ClinicalTrials.gov Identifier: NCT01171794     History of Changes
Other Study ID Numbers: SU-12012009-4443
First Submitted: July 27, 2010
First Posted: July 28, 2010
Results First Submitted: October 8, 2014
Results First Posted: April 20, 2017
Last Update Posted: April 20, 2017