Allergic RhinitisPhase 1NCT00796315
Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children
A Phase 1 study testing Doxylamine Succinate USP in people with Allergic Rhinitis and Upper Respiratory Infection, run by Procter and Gamble at 6 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis, Upper Respiratory Infection
- What is being tested?
- Doxylamine Succinate USP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 6 sitesUnited States
- Study dates
- Dec 2008to Jun 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Jeffrey L Blumer, MD, PhD
Cleveland, Ohio, 44106
Alex Kemper, Pharm D
Durham, North Carolina, 27705
Bridgette Jones, MD
Kansas City, Missouri, 64108
Janice E. Sullivan, MD
Louisville, Kentucky, 40202
Margaret Ann Springer, MD
Shreveport, Louisiana, 71103
Dana Best, MD
Washington D.C., District of Columbia, 20010
About this study
Official title: A Single-dose, Open-label, Multi-center Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children Ages 2 to < 18 Years
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
- Being tested
- Doxylamine Succinate USP
- Keywords
- Pharmacokinetic study
- Medical subject headings
- Rhinitis, Allergic, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxylamine Succinate USPDrug
Also called Doxylamine Succinate United States Pharmacopeia (USP)
One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL
| Study group | Role | What they receive |
|---|---|---|
| Doxylamine Succinate (USP) | Experimental | Doxylamine Succinate United States Pharmacopeia (USP) Receives: Drug: Doxylamine Succinate USP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 Hours
Cmax of Doxylamine
Maximum concentration of Doxylamine from 0 to 72 hours post-dose
Measured: 72 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Consumer Healthcare Products Association
- Responsible party
- Sponsor
- Investigators
- Molly Seeck, BS, JD, Study director, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796315
- Sponsor's protocol ID
- 2008014
- Status last verified
- Jan 2013
- First submitted
- 18 Nov 2008
- Last updated
- 4 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose, Open-label, Multi-center Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children Ages 2 to < 18 Years
- ClinicalTrials.gov ID
- NCT00796315
- Acronym / sponsor ID
- 2008014
- Conditions
- Allergic Rhinitis, Upper Respiratory Infection
- Keywords
- Pharmacokinetic study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Collaborators
- Consumer Healthcare Products Association
- Study start
- Dec 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 24 Nov 2008 (estimated)
- Results
- Posted 25 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Doxylamine Succinate (USP) | Experimental | Drug: Doxylamine Succinate USPDoxylamine Succinate United States Pharmacopeia (USP) |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxylamine Succinate USPAlso: Doxylamine Succinate United States Pharmacopeia (USP)One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL | Drug | Doxylamine Succinate (USP) |
Primary outcome
AUC of Doxylamine
Time frame: 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.
Cmax of Doxylamine
Time frame: 72 Hours
Maximum concentration of Doxylamine from 0 to 72 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Allergic Rhinitis
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Molly Seeck, BS, JD study director
Procter and Gamble
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Doxylamine Succinate USP in people with Allergic Rhinitis and Upper Respiratory Infection, run by Procter and Gamble at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC of Doxylamine (time frame: 72 Hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2013.