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Trial record 1 of 8 for:    UNISOM OR Unisom OR DOXYLAMINE OR Doxy-Sleep-Aid OR DOXYLAMINE SUCCINATE OR DECAPRYN OR Decapryn OR DOXY-SLEEP-AID
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Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children

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ClinicalTrials.gov Identifier: NCT00796315
Recruitment Status : Completed
First Posted : November 24, 2008
Results First Posted : January 25, 2013
Last Update Posted : February 4, 2013
Sponsor:
Collaborator:
Consumer Healthcare Products Association
Information provided by (Responsible Party):
Procter and Gamble

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Conditions Allergic Rhinitis
Upper Respiratory Infection
Intervention Drug: Doxylamine Succinate USP
Enrollment 41
Recruitment Details  
Pre-assignment Details Participant flow is described by three different age groups based on dosing differences for each group
Arm/Group Title Subjects Aged 2-5 Years (Doxylamine Succinate) Aged 6-11 Years (Doxylamine Succinate Subjects Aged 12-17 Years (Doxylamine Suc
Hide Arm/Group Description Ages 2-5 years. Doxylamine Succinate USP : One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL.

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.

Ages 12-17 years. Doxylamine Succinate USP : One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL.
Period Title: Overall Study
Started 9 17 15
Completed 9 16 15
Not Completed 0 1 0
Reason Not Completed
Protocol Violation             0             1             0
Arm/Group Title Doxylamine Succinate USP
Hide Arm/Group Description Doxylamine Succinate, United States Pharmacopeia (USP): One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL.
Overall Number of Baseline Participants 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
<=18 years
41
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants
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)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 41 participants
41
1.Primary Outcome
Title AUC of Doxylamine
Hide Description Area under the time-concentration curve for Doxylamine from 0 to 72 hours post-dose plus an extrapolated area from 72 hours to infinity.
Time Frame 72 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subjects Aged 2-5 Years Subjects Aged 6-11 Years Subjects Aged 12-17 Years
Hide Arm/Group Description:
Ages 2-5 years. Subjects received a dose of either 3.125 or 4.17 mg Doxylamine Succinate USP (exact dose dependent upon body weight)
Ages 6-11 years. Subjects received a dose of 4.17 or 6.25 or 8.33 or 10.42 mg Doxylamine Succinate USP (exact dose dependent upon body weight). Note: One subject (age group 6-11) was unable to meet protocol criteria (spit out a portion of his dosage) and was discontinued.
Ages 12-17 years. All subjects received a dose of 12.5 mg Doxylamine Succinate USP
Overall Number of Participants Analyzed 9 16 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
461.9
(51.2%)
810.1
(27.9%)
827.0
(45.4%)
2.Primary Outcome
Title Cmax of Doxylamine
Hide Description Maximum concentration of Doxylamine from 0 to 72 hours post-dose
Time Frame 72 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subjects Aged 2-5 Years Subjects Aged 6-11 Years Subjects Aged 12-17 Years
Hide Arm/Group Description:
Ages 2-5 years. Doxylamine Succinate USP
Ages 6-11 years. Doxylamine Succinate USP
Ages 12-17 years. Doxylamine Succinate USP
Overall Number of Participants Analyzed 9 16 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
50.1
(22.5%)
65.8
(19.9%)
63.2
(42.9%)
Time Frame Adverse Events collected until discharge from study, approximately 72 hours after dose
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Subjects Aged 2-5 Years Aged 6-11 Years Subjects Aged 12-17 Years
Hide Arm/Group Description Ages 2-5 years. Doxylamine Succinate USP Ages 6-11 years. Doxylamine Succinate USP Ages 12-17 years. Doxylamine succinate USP
All-Cause Mortality
Subjects Aged 2-5 Years Aged 6-11 Years Subjects Aged 12-17 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Subjects Aged 2-5 Years Aged 6-11 Years Subjects Aged 12-17 Years
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/17 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Subjects Aged 2-5 Years Aged 6-11 Years Subjects Aged 12-17 Years
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/9 (55.56%)      4/17 (23.53%)      7/15 (46.67%)    
Infections and infestations       
Otitis media acute * 1  0/9 (0.00%)  0 1/17 (5.88%)  1 0/15 (0.00%)  0
Nervous system disorders       
Sedation * 1  4/9 (44.44%)  5 3/17 (17.65%)  3 5/15 (33.33%)  5
Somnolence * 1  1/9 (11.11%)  1 0/17 (0.00%)  0 2/15 (13.33%)  2
Headache * 1  0/9 (0.00%)  0 0/17 (0.00%)  0 1/15 (6.67%)  1
Dizziness * 1  0/9 (0.00%)  0 0/17 (0.00%)  0 1/15 (6.67%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Medra
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
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 Investigator and Sub-Investigators agree that all data, calculations, interpretations, opinions, and recommendations regarding the study will be the property of the Sponsor. The Investigator agrees to consider the results as information subject to confidentiality and use restrictions.
Results Point of Contact
Name/Title: Guhan Balan
Organization: Procter & Gamble
Phone: 513.622.2657
Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT00796315     History of Changes
Other Study ID Numbers: 2008014
First Submitted: November 18, 2008
First Posted: November 24, 2008
Results First Submitted: December 19, 2012
Results First Posted: January 25, 2013
Last Update Posted: February 4, 2013