Trial Outcomes & Findings for Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children (NCT NCT00796315)

NCT ID: NCT00796315

Last Updated: 2013-02-04

Results Overview

Area under the time-concentration curve for Doxylamine from 0 to 72 hours post-dose plus an extrapolated area from 72 hours to infinity.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 41 participants
• Primary outcome timeframe: 72 Hours
• Results posted on: 2013-02-04

Participant Flow

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

Participant milestones

Measure	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.
Overall Study STARTED	9	17	15
Overall Study COMPLETED	9	16	15
Overall Study NOT COMPLETED	0	1	0

Reasons for withdrawal

Measure	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.
Overall Study Protocol Violation	0	1	0

Baseline Characteristics

Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children

Baseline characteristics by cohort

Measure	Doxylamine Succinate USP n=41 Participants Doxylamine Succinate, United States Pharmacopeia (USP): One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL.
Age, Categorical <=18 years	41 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age Continuous Subjects Aged 2-5 years	3.6 years STANDARD_DEVIATION 1.1 • n=93 Participants
Age Continuous Subjects Aged 6-11 years	8.5 years STANDARD_DEVIATION 1.5 • n=93 Participants
Age Continuous Subjects Aged 12-17 years	14.5 years STANDARD_DEVIATION 1.8 • n=93 Participants
Sex/Gender, Customized Male, Ages 2-5	7 participants n=93 Participants
Sex/Gender, Customized Female, Ages 2-5	2 participants n=93 Participants
Sex/Gender, Customized Male, Ages 6-11	9 participants n=93 Participants
Sex/Gender, Customized Female, Ages 6-11	8 participants n=93 Participants
Sex/Gender, Customized Male, Ages 12-17	9 participants n=93 Participants
Sex/Gender, Customized Female, Ages 12-17	6 participants n=93 Participants
Region of Enrollment United States	41 participants n=93 Participants

PRIMARY outcome

Timeframe: 72 Hours

Area under the time-concentration curve for Doxylamine from 0 to 72 hours post-dose plus an extrapolated area from 72 hours to infinity.

Outcome measures

Measure	Subjects Aged 2-5 Years n=9 Participants 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)	Subjects Aged 6-11 Years n=16 Participants 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.	Subjects Aged 12-17 Years n=15 Participants Ages 12-17 years. All subjects received a dose of 12.5 mg Doxylamine Succinate USP
AUC of Doxylamine	461.9 ng*h/mL Geometric Coefficient of Variation 51.2	810.1 ng*h/mL Geometric Coefficient of Variation 27.9	827.0 ng*h/mL Geometric Coefficient of Variation 45.4

PRIMARY outcome

Timeframe: 72 Hours

Maximum concentration of Doxylamine from 0 to 72 hours post-dose

Outcome measures

Measure	Subjects Aged 2-5 Years n=9 Participants 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)	Subjects Aged 6-11 Years n=16 Participants 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.	Subjects Aged 12-17 Years n=15 Participants Ages 12-17 years. All subjects received a dose of 12.5 mg Doxylamine Succinate USP
Cmax of Doxylamine	50.1 ng/mL Geometric Coefficient of Variation 22.5	65.8 ng/mL Geometric Coefficient of Variation 19.9	63.2 ng/mL Geometric Coefficient of Variation 42.9

Adverse Events

Subjects Aged 2-5 Years

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Aged 6-11 Years

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Subjects Aged 12-17 Years

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Subjects Aged 2-5 Years n=9 participants at risk Ages 2-5 years. Doxylamine Succinate USP	Aged 6-11 Years n=17 participants at risk Ages 6-11 years. Doxylamine Succinate USP	Subjects Aged 12-17 Years n=15 participants at risk Ages 12-17 years. Doxylamine succinate USP
Infections and infestations Otitis media acute	0.00% 0/9 • Adverse Events collected until discharge from study, approximately 72 hours after dose	5.9% 1/17 • Number of events 1 • Adverse Events collected until discharge from study, approximately 72 hours after dose	0.00% 0/15 • Adverse Events collected until discharge from study, approximately 72 hours after dose
Nervous system disorders Sedation	44.4% 4/9 • Number of events 5 • Adverse Events collected until discharge from study, approximately 72 hours after dose	17.6% 3/17 • Number of events 3 • Adverse Events collected until discharge from study, approximately 72 hours after dose	33.3% 5/15 • Number of events 5 • Adverse Events collected until discharge from study, approximately 72 hours after dose
Nervous system disorders Somnolence	11.1% 1/9 • Number of events 1 • Adverse Events collected until discharge from study, approximately 72 hours after dose	0.00% 0/17 • Adverse Events collected until discharge from study, approximately 72 hours after dose	13.3% 2/15 • Number of events 2 • Adverse Events collected until discharge from study, approximately 72 hours after dose
Nervous system disorders Headache	0.00% 0/9 • Adverse Events collected until discharge from study, approximately 72 hours after dose	0.00% 0/17 • Adverse Events collected until discharge from study, approximately 72 hours after dose	6.7% 1/15 • Number of events 1 • Adverse Events collected until discharge from study, approximately 72 hours after dose
Nervous system disorders Dizziness	0.00% 0/9 • Adverse Events collected until discharge from study, approximately 72 hours after dose	0.00% 0/17 • Adverse Events collected until discharge from study, approximately 72 hours after dose	6.7% 1/15 • Number of events 1 • Adverse Events collected until discharge from study, approximately 72 hours after dose

Additional Information

Guhan Balan

Procter & Gamble

Phone: 513.622.2657

Email: balan.g@pg.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER