Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children

NCT00796315 | Completed Phase 1 Results

• 1 other identifier: 2008014
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Allergic Rhinitis; Upper Respiratory Infection

Keywords

Pharmacokinetic study

Outcome Measures

Primary Outcomes (2)

• AUC of Doxylamine

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

  72 Hours

• Cmax of Doxylamine

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

  72 Hours

Study Arms (1)

Doxylamine Succinate (USP)

EXPERIMENTAL

Doxylamine Succinate United States Pharmacopeia (USP)

Drug: Doxylamine Succinate USP

Interventions

Doxylamine Succinate USP DRUG

One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL

Also known as: Doxylamine Succinate United States Pharmacopeia (USP)

Doxylamine Succinate (USP)

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 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)

Sponsors & Collaborators

• Procter and Gamble: lead
• Consumer Healthcare Products Association: collaborator

Study Sites (6)

Dana Best, MD

Washington D.C., District of Columbia, 20010, United States

Location

Janice E. Sullivan, MD

Louisville, Kentucky, 40202, United States

Location

Margaret Ann Springer, MD

Shreveport, Louisiana, 71103, United States

Location

Bridgette Jones, MD

Kansas City, Missouri, 64108, United States

Location

Alex Kemper, Pharm D

Durham, North Carolina, 27705, United States

Location

Jeffrey L Blumer, MD, PhD

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Infections

Limitations and Caveats

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

• Title: Guhan Balan
• Organization: Procter & Gamble

balan.g@pg.com

513.622.2657

Study Officials

• Molly Seeck, BS, JD

  Procter and Gamble

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2008
• First Posted: November 24, 2008
• Study Start: December 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: February 4, 2013
• Results First Posted: January 25, 2013

Record last verified: 2013-01

Locations

US (6)