A Multicenter Study to Evaluate Safety and Efficacy of Specific Immunotherapy With Modified Allergen Extracts
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ClinicalTrials.gov Identifier: NCT01012752 |
Recruitment Status
: Unknown
Verified November 2015 by Roxall Medizin.
Recruitment status was: Not yet recruiting
First Posted
: November 13, 2009
Last Update Posted
: November 3, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Allergic Rhinitis Allergic Conjunctivitis | Biological: modified allergen extract Biological: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, 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 |
Study Start Date : | October 2016 |
Estimated Primary Completion Date : | October 2017 |
Estimated Study Completion Date : | October 2017 |
Arm | Intervention/treatment |
---|---|
Active Comparator: modified allergen extract |
Biological: modified allergen extract
subcutaneous injections
|
Placebo Comparator: Placebo |
Biological: Placebo
subcutaneous injections
|
- Symptom and medication score [ Time Frame: 1 year ]
- Safety of the treatment [ Time Frame: 1 year ]
- Documentation of adverse events [ Time Frame: 1 year ]
- Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) [ Time Frame: 1 year ]
- Clinical global improvement [ Time Frame: 1 year ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01012752
Contact: Roxall Medizin | +49408972520 |
Germany | |
Hamburg, Germany |
Responsible Party: | Roxall Medizin |
ClinicalTrials.gov Identifier: | NCT01012752 History of Changes |
Other Study ID Numbers: |
SBC-2009-003B |
First Posted: | November 13, 2009 Key Record Dates |
Last Update Posted: | November 3, 2015 |
Last Verified: | November 2015 |
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 |