A Multicenter Study to Evaluate Safety and Efficacy of Specific Immunotherapy With Modified Allergen Extracts
This study is not yet open for participant recruitment.
(see Contacts and Locations)
Verified November 2015 by Roxall Medizin
Sponsor:
Roxall Medizin
Information provided by (Responsible Party):
Roxall Medizin
ClinicalTrials.gov Identifier:
NCT01012752
First received: November 11, 2009
Last updated: November 2, 2015
Last verified: November 2015
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Purpose
This trial is performed to evaluate the safety and clinical efficacy of subcutaneous specific immunotherapy in patients suffering from seasonal allergic rhinitis/rhinoconjunctivitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Allergic Rhinitis Allergic Conjunctivitis |
Biological: modified allergen extract Biological: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Double-Blind, Placebo-Controlled Study With a Modified Allergen Extract for Specific Immunotherapy in Patients With Seasonal Allergic Rhinitis/Rhinoconjunctivitis |
Further study details as provided by Roxall Medizin:
Primary Outcome Measures:
- Symptom and medication score [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Safety of the treatment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Documentation of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Clinical global improvement [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 150 |
| Study Start Date: | October 2016 |
| Estimated Study Completion Date: | October 2017 |
| Estimated Primary Completion Date: | October 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: modified allergen extract |
Biological: modified allergen extract
subcutaneous injections
|
| Placebo Comparator: Placebo |
Biological: Placebo
subcutaneous injections
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Positive history of allergen specific allergic rhinitis/rhinoconjunctivitis
- 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 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,
- Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.
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: NCT01012752
Please refer to this study by its ClinicalTrials.gov identifier: NCT01012752
Contacts
| Contact: Roxall Medizin | +49408972520 |
Locations
| Germany | |
| Hamburg, Germany | |
Sponsors and Collaborators
Roxall Medizin
More Information
| Responsible Party: | Roxall Medizin |
| ClinicalTrials.gov Identifier: | NCT01012752 History of Changes |
| Other Study ID Numbers: | SBC-2009-003B |
| Study First Received: | November 11, 2009 |
| Last Updated: | November 2, 2015 |
| Health Authority: | Germany: Paul-Ehrlich-Institut |
Additional relevant MeSH terms:
|
Rhinitis Rhinitis, Allergic Conjunctivitis Conjunctivitis, Allergic Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Conjunctival Diseases Eye Diseases |
ClinicalTrials.gov processed this record on September 30, 2016