Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children

This study has been completed.
Sponsor:
Collaborator:
Consumer Healthcare Products Association
Information provided by (Responsible Party):
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT00796315
First received: November 18, 2008
Last updated: January 29, 2013
Last verified: January 2013
Results First Received: December 19, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Conditions: Allergic Rhinitis
Upper Respiratory Infection
Intervention: Drug: Doxylamine Succinate USP

  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
Participant flow is described by three different age groups based on dosing differences for each group

Reporting Groups
  Description
Subjects Aged 2-5 Years (Doxylamine Succinate) Ages 2-5 years. Doxylamine Succinate USP : One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL.
Aged 6-11 Years (Doxylamine Succinate

Ages 6-11 years. Doxylamine Succinate USP : One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL.

Note: One subject (age group 6-11) was unable to meet protocol criteria (spit out a portion of his dosage) and was discontinued.

Subjects Aged 12-17 Years (Doxylamine Suc Ages 12-17 years. Doxylamine Succinate USP : One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL.

Participant Flow:   Overall Study
    Subjects Aged 2-5 Years (Doxylamine Succinate)     Aged 6-11 Years (Doxylamine Succinate     Subjects Aged 12-17 Years (Doxylamine Suc  
STARTED     9     17     15  
COMPLETED     9     16     15  
NOT COMPLETED     0     1     0  
Protocol Violation                 0                 1                 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.
No text entered.

Reporting Groups
  Description
Doxylamine Succinate USP Doxylamine Succinate, United States Pharmacopeia (USP): One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL.

Baseline Measures
    Doxylamine Succinate USP  
Number of Participants  
[units: participants]
  41  
Age  
[units: participants]
 
<=18 years     41  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
 
Subjects Aged 2-5 years     3.6  ± 1.1  
Subjects Aged 6-11 years     8.5  ± 1.5  
Subjects Aged 12-17 years     14.5  ± 1.8  
Gender, Customized  
[units: participants]
 
Male, Ages 2-5     7  
Female, Ages 2-5     2  
Male, Ages 6-11     9  
Female, Ages 6-11     8  
Male, Ages 12-17     9  
Female, Ages 12-17     6  
Region of Enrollment  
[units: participants]
 
United States     41  



  Outcome Measures
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1.  Primary:   AUC of Doxylamine   [ Time Frame: 72 Hours ]

2.  Primary:   Cmax of Doxylamine   [ Time Frame: 72 Hours ]


  Serious Adverse Events


  Other Adverse Events


  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
Incidences of mild sedation are consistent with doxylamine's indication as an OTC sleep aid. Conclusive evaluation of sedation couldn't be undertaken in the absence of a control group. Also, children may nap in daytime confounding sedation assessment  


Results Point of Contact:  
Name/Title: Guhan Balan
Organization: Procter & Gamble
phone: 513.622.2657
e-mail: balan.g@pg.com


No publications provided


Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT00796315     History of Changes
Other Study ID Numbers: 2008014
Study First Received: November 18, 2008
Results First Received: December 19, 2012
Last Updated: January 29, 2013
Health Authority: United States: Food and Drug Administration