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Nitric Oxide Inhalation to Treat Sickle Cell Pain Crises
This study has been completed.
Study NCT00094887   Information provided by INO Therapeutics

First Received on October 28, 2004.   Last Updated on August 10, 2011   History of Changes
Results First Received: December 4, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Anemia, Sickle Cell
Interventions: Drug: Nitric Oxide
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
Multicenter; 11 study centers enrolled subjects Date first subject enrolled: 13 April, 2005 Date last subject completed: 15 December, 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Inhaled Nitric Oxide Inhaled Nitric Oxide INO
Placebo Nitrogen gas

Participant Flow:   Overall Study
    Inhaled Nitric Oxide     Placebo  
STARTED     75 [1]   75 [1]
COMPLETED     70     69  
NOT COMPLETED     5     6  
Family emergency, Subject noncompliance                 3                 4  
Physician Decision                 2                 2  
[1] 75



  Baseline Characteristics
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Reporting Groups
  Description
Inhaled Nitric Oxide Inhaled Nitric Oxide INO
Placebo Nitrogen gas

Baseline Measures
    Inhaled Nitric Oxide     Placebo     Total  
Number of Participants  
[units: participants]
 		  75     75     150  
Age, Customized  
[units: participants]
 		     
< 16 years     12     14     26  
>=16 years     63     61     124  
Age  
[units: years]
Mean ± Standard Deviation 		  26.6  ± 11.06     26.0  ± 10.49     26.3  ± 10.75  
Gender  
[units: participants]
 		     
Female     38     37     75  
Male     37     38     75  
Region of Enrollment  
[units: participants]
 		     
United States     75     75     150  



  Outcome Measures

1.  Primary:   Time to Resolution of Vaso-occlusive Pain Crisis (VOC)   [ Time Frame: Up to 30 days ]
  Show Outcome Measure 1

2.  Secondary:   Vital Signs   [ Time Frame: At baseline, then every hour for the first 8 hours of therapy, followed by every 4 hours of therapy. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Methemoglobin Levels   [ Time Frame: at 2,4,6, and 8 hours after the start of therapy and then every 24 hours while on therapy. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Need for Analgesics   [ Time Frame: baseline and throughout treatment. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Blood Chemistry Levels   [ Time Frame: every 24 hours for the first 5 days after start of treatment. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Length of Hospitalization From Admissions Defined by the Time of the Discharge Order is Written   [ Time Frame: study duration ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Rate of Acute Chest Syndrome/Pneumonia Requiring Blood Transfusion   [ Time Frame: study duration ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: James Baldassare, MD
Organization: INO Therapeutics LLC
phone: 908-238-6603
e-mail: james.baldassare@ikaria.com


Publications:
Sanders DY, Severance HW, Pollack CV Jr. Sickle cell vaso-occlusive pain crisis in adults: alternative strategies for management in the emergency department. South Med J. 1992 Aug;85(8):808-11.

Publications automatically indexed to this study:
Gladwin MT, Kato GJ, Weiner D, Onyekwere OC, Dampier C, Hsu L, Hagar RW, Howard T, Nuss R, Okam MM, Tremonti CK, Berman B, Villella A, Krishnamurti L, Lanzkron S, Castro O, Gordeuk VR, Coles WA, Peters-Lawrence M, Nichols J, Hall MK, Hildesheim M, Blackwelder WC, Baldassarre J, Casella JF; DeNOVO Investigators. Nitric oxide for inhalation in the acute treatment of sickle cell pain crisis: a randomized controlled trial. JAMA. 2011 Mar 2;305(9):893-902.


Responsible Party: James Baldassarre, INO Therapeutics
ClinicalTrials.gov Identifier: NCT00094887     History of Changes
Obsolete Identifiers: NCT00652535
Other Study ID Numbers: 050019, INOT 36, 05-H-0019
Study First Received: October 28, 2004
Results First Received: December 4, 2009
Last Updated: August 10, 2011
Health Authority: United States: Food and Drug Administration





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