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
  Purpose

The primary goal of this study is to characterize the pharmacokinetics of doxylamine succinate in children ages 2 to < 18 years. Once characterized, these pediatric pharmacokinetic data will be pooled with historical adult PK data from other studies to assess whether the existing Over-the-Counter (OTC)doses provide comparable systemic drug exposure as that associated with efficacy in adults.


Condition Intervention Phase
Allergic Rhinitis
Upper Respiratory Infection
Drug: Doxylamine Succinate USP
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Single-dose, Open-label, Multi-center Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children Ages 2 to < 18 Years

Resource links provided by NLM:


Further study details as provided by Procter and Gamble:

Primary Outcome Measures:
  • AUC of Doxylamine [ Time Frame: 72 Hours ] [ Designated as safety issue: No ]
    Area under the time-concentration curve for Doxylamine from 0 to 72 hours post-dose plus an extrapolated area from 72 hours to infinity.

  • Cmax of Doxylamine [ Time Frame: 72 Hours ] [ Designated as safety issue: No ]
    Maximum concentration of Doxylamine from 0 to 72 hours post-dose


Enrollment: 41
Study Start Date: December 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Doxylamine Succinate (USP)
Doxylamine Succinate United States Pharmacopeia (USP)
Drug: Doxylamine Succinate USP
One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL
Other Name: Doxylamine Succinate United States Pharmacopeia (USP)

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • are male or female children ages 2 to < 18 years, with a minimum weight of 24 lbs and > 5th percentile and < 95th percentile for weight based on age and sex, at the time of dosing study medication
  • had a previous diagnosis of allergic rhinitis, or had a history of frequent upper respiratory infections (URI)/common cold and either be symptomatic, or at risk for future URI, including each of the following 3 criteria

    • Frequency Criterion: > 6 infections per year for children aged 2 to <6 years of age and > 4 infections per year for children aged 6 to < 18 years of age
    • Crowding Criterion: 4 persons living in the home or 3 persons sleeping in one bedroom
    • Exposure Criterion: another family member in the home who is ill with URI / common cold or a child in the family who is attending preschool or school with 6 children in the group.
  • are in good general health
  • are likely to be compliant and complete the study and have parent(s) or legally authorized representative(s) likely to be compliant and complete the study according to the Investigator
  • whose parent(s) or legally authorized representative(s) have signed and dated an Institutional Review Board (IRB)-approved consent form for the subject to participate in the study
  • must have signed an assent form as required by the site's IRB
  • if post-menarchal females, subjects must have a negative urine pregnancy test at screening and check-in, or serum pregnancy test at screening, if site required;
  • if post-menarchal females, subjects must practice abstinence or use an effective form of birth control (eg, intrauterine device, low dose oral contraceptives [ 50g ethinyl estradiol], contraceptive implants or injections, diaphragm with spermicide, cervical cap, or consort use of condom) for at least 3 months before being enrolled in the study.

Exclusion Criteria:

  • has any history or presence of the following medical conditions: peptic ulcer, pyloroduodenal obstruction or other gastrointestinal disease; renal or hepatic disease; diabetes mellitus; hyperthyroidism; cardiovascular disease;increased ocular pressure or glaucoma; endocrine, metabolic, hematologic or neoplastic disease; seizure disorder; chronic respiratory diseases including asthma, emphysema and chronic bronchitis; autoimmune disease; immunodeficiency tuberculosis; bladder neck obstruction; significant dermatologic condition.
  • has a known sensitivity or allergy to doxylamine succinate
  • has a history of a severe allergic reaction to any drug or has multiple food/drug allergies
  • experienced febrile illness greater than 100°F within 7 days prior to dosing
  • reports any known enzyme-inducer, enzyme-inhibitor, or reported chronic exposure to enzyme-inducers such as paint solvents or pesticides within 30 days prior to dosing, unless approved by the Sponsor
  • reports any other prescription drug or herbal remedy usage within 14 days prior to dosing except for low dose contraceptives, unless approved by the Sponsor
  • reports any non-prescription drug or supplemental vitamin usage within 5 days prior to dosing
  • unwillingness to refrain from caffeine or other xanthine-containing beverages, including coffee and tea, alcohol, grapefruit juice, chocolate, or Seville oranges 24 hours prior to admission and throughout the study
  • reported use of tobacco, smoking cessation products, or products containing nicotine within 3 months prior to Screening
  • has an acute illness (except as described in Section 3.3.1 Inclusion Criterion b) within 14 days prior to dosing; unless approved by the Sponsor;
  • has any laboratory value outside the laboratory reference range considered clinically significant by the Investigator
  • has a history or diagnosis of Hepatitis B, Hepatitis C, human immunodeficiency virus (HIV), or thyroid disease
  • has a history of alcohol or illicit drug use or a positive urine drug of abuse screen
  • are pregnant or lactating (post-menarchal female subjects should be made aware that pregnancy testing will occur during the study, and that if they are sexually active they must take appropriate steps to ensure they do not become pregnant during the study)
  • has made a blood donation or plasma donation within 4 weeks prior to dosing;
  • has participated in another investigational drug study protocol within 30 days prior to dosing (Day -1)
  • has a history or presence, upon clinical evaluation, of any illness or condition that might impact safety of the subject with test product administration or evaluability of drug effect, based on the Investigator's discretion
  • is unable to avoid driving, operating machinery, or other tasks that require alertness during the study.
  • is unable or unwilling to avoid contact sports, strenuous exercises (e.g. weight lifting), exercises for which they are not trained or conditioned or intramuscular injection for at least 1 week before baseline visit when creatine phosphokinase (CPK) will be evaluated
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796315

Locations
United States, District of Columbia
Dana Best, MD
Washington, District of Columbia, United States, 20010
United States, Kentucky
Janice E. Sullivan, MD
Louisville, Kentucky, United States, 40202
United States, Louisiana
Margaret Ann Springer, MD
Shreveport, Louisiana, United States, 71103
United States, Missouri
Bridgette Jones, MD
Kansas City, Missouri, United States, 64108
United States, North Carolina
Alex Kemper, Pharm D
Durham, North Carolina, United States, 27705
United States, Ohio
Jeffrey L Blumer, MD, PhD
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Procter and Gamble
Consumer Healthcare Products Association
Investigators
Study Director: Molly Seeck, BS, JD Procter and Gamble
  More Information

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

Keywords provided by Procter and Gamble:
Pharmacokinetic study

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Doxylamine
Doxylamine succinate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014