Over-the-Counter Medication Usage

Medication Systems Clinical Trial

Official title:

Improving Over-the-counter Medication Compliance.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00439348
• Other study ID #: 07.02.01
• Status: Completed
• Phase: N/A
• First received: February 21, 2007
• Last updated: November 20, 2009
• Start date: February 2007
• Est. completion date: February 2009

Study information

• Verified date: November 2009
• Source: Florida Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

There are several benefits of over-the-counter medications, yet there is little research evaluating how to increase patient compliance when a health care provider suggests an over-the-counter (OTC) medication. We are evaluating two types of physician directions to see which increases patient compliance with OTC medications.

Description:

Researchers will identify a cohort of gynecologic patients presenting for annual examinations and offer participation in the study. Physician researchers will randomize patients to 2 types of physician directions about OTC medications, then follow compliance over the course of the next 7 months. A total of 123 participants in each arm will undergo recruitment, until a total of 246 participants are recruited.

Inclusion criteria include: female, non-pregnant patients presenting for annual gynecologic examinations between the ages of 19-50.

Exclusion criteria include: outside of study age range, patient taking thyroid medication, history of kidney stones, history of hypercalcemia, non-English speaking.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: February 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 50 Years

Eligibility

Inclusion Criteria:

• Female patients undergoing annual gynecologic examinations.

• Ages 19-50.

• Patients not currently taking certain OTC medications.

Exclusion Criteria:

• Pregnancy.

• History of hypercalcemia.

• History of kidney stones.

• Outside study age range of 19-50.

• Patient taking thyroid medication.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drugs, Non-Prescription
• Medication Systems

Intervention

Behavioral:
• Verbal advice
Patients receive verbal advice regarding specific over-the-counter medications.
• Prescription
Patients receive a prescription for a specific over-the-counter medication.

Locations

Country	Name	City	State
United States	Loch Haven Ob/Gyn Group	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determining which of 2 types of physician direction regarding OTC medication usage improves patients compliance, as assessed at 3 and 6 months after enrollment.		3 and 6 months after enrollment.	No