Evaluation of Safety of ZyComb® In Patients With Common Cold - ZIP 3000 (XY-005-IM)
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| ClinicalTrials.gov Identifier: NCT00480194 |
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Recruitment Status :
Completed
First Posted : May 30, 2007
Last Update Posted : May 7, 2012
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Sponsor:
Nycomed
Information provided by:
Nycomed
- Study Details
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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 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:
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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:
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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 |