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

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ClinicalTrials.gov Identifier: NCT00480194
Recruitment Status : Completed
First Posted : May 30, 2007
Last Update Posted : May 7, 2012
Sponsor:
Information provided by:
Nycomed

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 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
U.S. FDA Resources


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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.

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
Study Chair: Nycomed Clinical Trial Operations Headquaters

Responsible Party: Nycomed
ClinicalTrials.gov Identifier: NCT00480194     History of Changes
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:
Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Bromides
Ipratropium
Xylometazoline
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