Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT01118858
Eligibility Criteria:
Inclusion Criteria:
* Males and females between 7 and 15 years of age.
Exclusion Criteria:
* Inability to have blood drawn for the screening lab tests
* Current therapy with medications known to inhibit CYP2D6: \*fluoxetine (Prozac®)
* sertraline (Zoloft®)
* paroxetine (Paxil®)
* venlafaxine (Effexor®)
* imipramine
* nortriptyline
* desipramine
* amitriptyline
* fenfluramine
* terbinafine
* cyclobenzaprine
* haloperidol (Haldol®)
* metoprolol
* quinidine
* propafenone (Rythmol®)
* cimetidine (Tagamet®)
* tamoxifen
* over-the-counter diphenhydramine-containing drugs
* including Benadryl and generics and the cough and cold preparations
* Dytuss®
* Tusstat®
* Robitussin®
* pro-drugs codeine
* tramadol
* hydrocodone
* oxycodone (Percodan®, Percocet®) that are converted by 2D6 into their active forms.
* Illicit drug use, treatment within the past 2 months with paroxetine or fluoxetine, or the past six months with terbinafine are also exclusion criteria.
* Inability or unwillingness to fast 2 hours prior to the study session
* Existence of diagnosis which may influence absorption and gastric emptying; such as reflux , inflammatory bowel disease, or Crohn's disease.
* A demonstrated adverse reaction to previous dextromethorphan exposure
* Impaired hepatic or renal activity, or physical examination as determined by the Sub Investigator's discretion.
* Pregnancy
* Body-mass index (BMI) \<5th percentile
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
15 Years
Study:
NCT01118858
Study Brief:
Protocol Section:
NCT01118858