Trial record 2 of 19 for:
Open Studies | "Rhinitis, Allergic, Seasonal"
Observational Study With PASCALLERG ® in Patients With Hay Fever
This study is currently recruiting participants.
Verified August 2012 by Pascoe Pharmazeutische Praeparate GmbH
Sponsor:
Pascoe Pharmazeutische Praeparate GmbH
Information provided by (Responsible Party):
Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier:
NCT01660737
First received: August 1, 2012
Last updated: August 13, 2012
Last verified: August 2012
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Purpose
The aim of this observational study is to document the therapeutic use of PASCALLERG ® for hay fever. Based on the survey is a decrease in disease-specific symptoms when taking PASCALLERG ® over a period of 4 weeks will be documented. In addition to the compatibility can be assessed.
| Condition |
|---|
|
Hay Fever |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Observational Study With PASCALLERG ® in Patients With Hay Fever |
Resource links provided by NLM:
Further study details as provided by Pascoe Pharmazeutische Praeparate GmbH:
Primary Outcome Measures:
- Efficacy of Pascallerg [ Time Frame: on average 4 weeks ] [ Designated as safety issue: No ]Request of Efficacy using a 4-stage scale (very good efficacy, good efficacy, moderate efficacy, no efficacy)
- Tolerability [ Time Frame: on average 4 weeks ] [ Designated as safety issue: No ]Request of Tolerability using a 2-stage scale (very good tolerability, bad tolerability)
Secondary Outcome Measures:
- Numerical Rating Scale [ Time Frame: on average 4 weeks ] [ Designated as safety issue: No ]Influence of allergy on the general well-being (scale from 0-no influence to 10 strong influence)
- Dry eyes [ Time Frame: on average 4 weeks ] [ Designated as safety issue: No ]Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)
- Itching eyes [ Time Frame: on average 4 weeks ] [ Designated as safety issue: No ]Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)
- Burning eyes [ Time Frame: on average 4 weeks ] [ Designated as safety issue: No ]Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)
- Bronchial complaints [ Time Frame: on average 4 weeks ] [ Designated as safety issue: No ]Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)
- Sneezing [ Time Frame: on average 4 weeks ] [ Designated as safety issue: No ]Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)
- Rhinitis [ Time Frame: on average 4 weeks ] [ Designated as safety issue: No ]Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)
- Fatigue / Tiredness [ Time Frame: on average 4 weeks ] [ Designated as safety issue: No ]Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)
- Headache [ Time Frame: on average 4 weeks ] [ Designated as safety issue: No ]Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)
- Tearing eyes [ Time Frame: on average 4 weeks ] [ Designated as safety issue: No ]Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)
Other Outcome Measures:
- Dosage of Pascallerg [ Time Frame: on average 4 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
PASCALLERG® tablets in patients with hay fever
Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
|
Detailed Description:
There are documented male and female patients over the age of one year who suffer from hay fever. The traetment time is about a period of 4 weeks with PASCALLERG® tablets.
Eligibility| Ages Eligible for Study: | 1 Year and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
patients from natural practioners and doctors from Germany
Criteria
Inclusion Criteria:
- hay fever
Exclusion Criteria:
- Lactose intolerance and / or
- Chromium hypersensitivity
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01660737
Contacts
| Contact: Jennifer Lebert, Study Manager | 0049(641)-7960955 | Jennifer.lebert@pascoe.de |
| Contact: Bianka Krick | 0049(641)-7960963 | Bianka.Krick@pascoe.de |
Locations
| Germany | |
| Jennifer Lebert | Recruiting |
| Gießen, Germany, 35390 | |
| Contact: Jennifer Lebert, Study Manager 0049(641)-7960955 | |
Sponsors and Collaborators
Pascoe Pharmazeutische Praeparate GmbH
More Information
No publications provided
| Responsible Party: | Pascoe Pharmazeutische Praeparate GmbH |
| ClinicalTrials.gov Identifier: | NCT01660737 History of Changes |
| Other Study ID Numbers: | 180A12PALL |
| Study First Received: | August 1, 2012 |
| Last Updated: | August 13, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Pascoe Pharmazeutische Praeparate GmbH:
|
Hay fever Pascallerg |
Additional relevant MeSH terms:
|
Rhinitis, Allergic, Seasonal Fever Body Temperature Changes Signs and Symptoms Rhinitis Nose Diseases |
Respiratory Tract Diseases Respiratory Hypersensitivity Otorhinolaryngologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013