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

This study has been completed.

Sponsor:

Information provided by:

Nycomed

ClinicalTrials.gov Identifier:

NCT00480194

First received: May 24, 2007

Last updated: May 4, 2012

Last verified: February 2008

History of Changes

Purpose

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.

Condition	Intervention
Common Cold	Drug: xylometazoline hydrochloride and ipratropium bromide (ZyComb)


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Common Cold

Drug Information available for: Xylometazoline Xylometazoline hydrochloride Ipratropium bromide

U.S. FDA Resources

Further study details as provided by Nycomed:


Estimated Enrollment:	1000
Study Start Date:	December 2006
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Common cold in a real-life OTC setting

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

For inclusion the patient must buy ZyComb® nasal spray with the intention to start using it either the same or the next day. Male or female patients over 18 years of age, visiting any of the participating pharmacies are eligible for inclusion.

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480194

Sponsors and Collaborators

Nycomed

Investigators


Study Chair:	Nycomed Clinical Trial Operations	Headquaters

More Information

No publications provided


Responsible Party:	Nycomed
ClinicalTrials.gov Identifier:	NCT00480194 History of Changes
Other Study ID Numbers:	XY-005-IM
Study First Received:	May 24, 2007
Last Updated:	May 4, 2012
Health Authority:	Sweden: Medical Products Agency

Additional relevant MeSH terms:


Common Cold Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases Ipratropium Xylometazoline Anti-Asthmatic Agents Autonomic Agents Bronchodilator Agents Cardiovascular Agents	Cholinergic Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Nasal Decongestants Neurotransmitter Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Respiratory System Agents Therapeutic Uses Vasoconstrictor Agents

ClinicalTrials.gov processed this record on February 27, 2015

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