Efficacy and Safety of Specific Immunotherapy With CLUSTO... | NCT01012531

Studies
Efficacy and Safety of Specific Immunotherapy With CLUSTOID Grass Pollen

NCT01012531

Sponsor

Roxall Medizin

Status

Completed

Last Update Posted

Jul 14, 2011Estimated

Enrollment

121Actual

Phase

Phase 3

Conditions

Allergic Rhinitis

Interventions

Subcutaneous injections with highly polymerized allergen extract
Subcutaneous injection with placebo

Countries

Germany

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

Nov 2009

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

Oct 2008

Primary Completion Date

Nov 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Nov 11, 2009

First Submission Date that Met QC Criteria

Nov 12, 2009

First Posted Date

Nov 13, 2009Estimated

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

Jul 13, 2011

Last Update Posted Date

Jul 14, 2011Estimated

Design Module

Study Type

Interventional

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

121Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
highly polymerized allergen extract	Active Comparator		Biological: Subcutaneous injections with highly polymerized allergen extract
Placebo	Placebo Comparator		Biological: Subcutaneous injection with placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Subcutaneous injections with highly polymerized allergen extract	Biological	cluster schedule	highly polymerized allergen extract

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Symptom and medication score		1 year

Secondary Outcomes

Measure	Description	Time Frame
Safety of the treatment during the study period		1 year
Documentation of adverse events		1 year
Individual symptom scores of the rhinoconjunctivitis symptom score (RSS) during the pollen season

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Positive history of allergic rhinitis/rhinoconjunctivitis due to grass and/or rye pollen
Positive screening skin prick test (wheal diameter > 3 mm)
Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication
Signed and dated patient´s Informed Consent,

Exclusion Criteria:

Previous immunotherapy with grass and/or rye pollen extracts within the last 3 years,
Simultaneous participation in other clinical trials,
Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance),
Auto-immune disorders,
Severe chronic inflammatory diseases,
Malignancy,
Alcohol abuse,
Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection,
Patients being in any relationship or dependency with the sponsor and/or investigator,
Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065631	Rhinitis, Allergic

Ancestor Terms

ID	Term
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007279	Injections, Subcutaneous

Ancestor Terms

ID	Term
D007267	Injections
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided