Trial record 17 of 225 for:    Open Studies | "Fever"

Observational Study With PASCALLERG ® in Patients With Hay Fever

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Pascoe Pharmazeutische Praeparate GmbH
Sponsor:
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
  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
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: 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:
Fever
Rhinitis, Allergic, Seasonal
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 July 29, 2014