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Evaluation of Safety of ZyComb® In Patients With Common Cold - ZIP 3000 (XY-005-IM)
This study has been completed.
Sponsor:
Nycomed
Information provided by:
Nycomed
ClinicalTrials.gov Identifier:
NCT00480194
First received: May 24, 2007
Last updated: May 4, 2012
Last verified: February 2008
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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:
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:
-
Drug: xylometazoline hydrochloride and ipratropium bromide (ZyComb)
Common cold in a real-life OTC setting
Eligibility| 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.
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
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
| 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 |
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 |
ClinicalTrials.gov processed this record on September 18, 2017