Common ColdNCT00480194
Evaluation of Safety of ZyComb® In Patients With Common Cold - ZIP 3000 (XY-005-IM)
An observational study of Common Cold, run by Nycomed.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Common Cold
- What is being tested?
- xylometazoline hydrochloride and ipratropium bromide (ZyComb)
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Jan 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- For inclusion the patient must buy ZyComb® nasal spray with the intention to start using it either the same or the next day.
Who cannot join
None listed.
About this study
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
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.
- Conditions
- Common Cold
- Being tested
- xylometazoline hydrochloride and ipratropium bromide (ZyComb)
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xylometazoline hydrochloride and ipratropium bromide (ZyComb)Drug
Common cold in a real-life OTC setting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2007 (estimated)
- Study startDec 2006
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common ColdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nycomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nycomed Clinical Trial Operations, Study chair, Headquaters
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480194
- Sponsor's protocol ID
- XY-005-IM
- Status last verified
- Feb 2008
- First submitted
- 24 May 2007
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00480194
- Acronym / sponsor ID
- XY-005-IM
- Conditions
- Common Cold
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- NycomedIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 30 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- For inclusion the patient must buy ZyComb® nasal spray with the intention to start using it either the same or the next day.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| xylometazoline hydrochloride and ipratropium bromide (ZyComb)Common cold in a real-life OTC setting | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nycomed Clinical Trial Operations study chair
Headquaters
Questions about this trial
What is this clinical trial studying?
An observational study of Common Cold, run by Nycomed.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2012.