Evaluation of Safety of ZyComb® In Patients With Common Cold - ZIP 3000 (XY-005-IM)

Common Cold Clinical Trial

Official title:

A Non-interventional, Non-controlled, Post-marketing Study to Obtain Knowledge of the Safety of ZyComb® (Xylometazoline Hydrochloride 0.5 mg/mL and Ipratropium Bromide 0.6 mg/mL) for Symptoms of Common Cold in a Real-life OTC Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00480194
• Other study ID #: XY-005-IM
• Status: Completed
• Phase: N/A
• First received: May 24, 2007
• Last updated: May 4, 2012
• Start date: December 2006
• Est. completion date: January 2008

Study information

• Verified date: February 2008
• Source: Nycomed
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Observational

Clinical Trial Summary

The objectives of the study are to obtain knowledge about the safety in use, the patients' general impression of the treatment and the pattern of use of ZyComb® in an over-the-counter (OTC) setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• For inclusion the patient must buy ZyComb® nasal spray with the intention to start using it either the same or the next day.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Common Cold

Intervention

Drug:
• xylometazoline hydrochloride and ipratropium bromide (ZyComb)
Common cold in a real-life OTC setting

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nycomed