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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00480194
Recruitment Status : Completed
First Posted : May 30, 2007
Last Update Posted : May 7, 2012
Sponsor:
Information provided by:
Nycomed

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Common Cold Drug: xylometazoline hydrochloride and ipratropium bromide (ZyComb)

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
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
Study Start Date : December 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Common Cold

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

Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00480194


Sponsors and Collaborators
Nycomed
Investigators
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Study Chair: Nycomed Clinical Trial Operations Headquaters
More Information
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Responsible Party: Nycomed
ClinicalTrials.gov Identifier: NCT00480194    
Other Study ID Numbers: XY-005-IM
First Posted: May 30, 2007    Key Record Dates
Last Update Posted: May 7, 2012
Last Verified: February 2008
Additional relevant MeSH terms:
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Common Cold
Respiratory Tract Infections
Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Xylometazoline
Bromides
Ipratropium
Anticonvulsants
Bronchodilator Agents
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nasal Decongestants
Vasoconstrictor Agents