Evaluation of Safety of ZyComb® In Patients With Common C... | NCT00480194

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

NCT00480194

Sponsor

Nycomed

Status

Completed

Last Update Posted

May 7, 2012Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Common Cold

Interventions

xylometazoline hydrochloride and ipratropium bromide (ZyComb)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Jan 2008Actual

Completion Date

Jan 2008Actual

First Submitted Date

May 24, 2007

First Submission Date that Met QC Criteria

May 29, 2007

First Posted Date

May 30, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2012

Last Update Posted Date

May 7, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
xylometazoline hydrochloride and ipratropium bromide (ZyComb)	Drug	Common cold in a real-life OTC setting

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

Name	Affiliation	Role
Nycomed Clinical Trial Operations	Headquaters	Study Chair

Condition Browse Module

MeSH Terms

ID	Term
D003139	Common Cold

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D010850	Picornaviridae Infections
D012327	RNA Virus Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C009695	xylometazoline
D009241	Ipratropium

Ancestor Terms

ID	Term
D001286	Atropine Derivatives
D014326	Tropanes
D053961	Azabicyclo Compounds
D001372	Aza Compounds

Browse Leaves

Not provided

Browse Branches

Not provided