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...
Date First Received: May 24, 2007
Last Updated: February 26, 2008
Verified by: Nycomed, February 2008
Clinical Trial Phase: N/A | Start Date: December 2006
Overall Status: Completed
Estimated Enrollment: 1000
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Observational
Study Design: Case-Only, Prospective
Study Primary Completion Date: January 2008
Intervention(s) in this Clinical Trial
- Drug: xylometazoline hydrochloride and ipratropium bromide (ZyComb)
- Common cold in a real-life OTC setting
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Nycomed
Overall Clinical Trial Officials and Contacts
Nycomed Clinical Trial Operations Study Chair Headquaters
Additional Information
Information obtained from ClinicalTrials.gov on November 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00480194
Study ID Number: XY-005-IM
ClinicalTrials.gov Identifier: NCT00480194
Health Authority: Sweden: Medical Products Agency
Clinical Trials Authorship and Review
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