Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2005-001584-66-DE
EUCTR2005-001584-66-DE
Active, not recruiting
Not Applicable

A randomised controlled multicentre study for the safety of Depigoid(R)rush schedule

ETI Pharma GmbH0 sites320 target enrollmentJuly 13, 2005
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsRhinitis and/or rhinoconjunctivitis without uncontrolled asthma caused by clinical relevant sensitisation againts tree pollen, grass pollen or house dust mitesMedDRA version: 8.0Level: LLTClassification code 10001723

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rhinitis and/or rhinoconjunctivitis without uncontrolled asthma caused by clinical relevant sensitisation againts tree pollen, grass pollen or house dust mites
Sponsor
ETI Pharma GmbH
Enrollment
320
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 13, 2005
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
ETI Pharma GmbH

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients of both gender aged from 18 up to 65 years
  • •2\. Prior to study specific examinations the patient has to give his/her written in\-formed consent.
  • •3\. FEV1 or PEF \> 70% of predicted normal value under normal conditions
  • •4\. FEV1 or PEF \> 80% of predicted normal value directly before injection
  • •5\. The patients have to suffer from allergic complaints (rhinitis and/or rhinoconjunctivitis without uncontrolled allergic asthma) caused by clinical sensitisation against tree pollen, grass pollen or house dust mites. Polysensitised patients can also be included. The IgE mediated sensitisation has to be verified by
  • •· suggestive medical history
  • •· a positive skin prick test LETI for tree pollen, grass pollen or house dust mites, resulting in a wheal diameter of at least 3 mm \> negative control re\-action or '\+\+' versus histamine
  • •· specific IgE \> 1 (CAP\-RAST)
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:

Exclusion Criteria

  • •1\. Pregnant or lactating women
  • •2\. Women of child\-bearing age not employing sufficient contraceptive protection (contraceptive medication or condom)
  • •3\. Participation in another clinical trial within the last 3 months prior to this study
  • •4\. Smokers with a manifested bronchopathy
  • •5\. Alcohol\- or drug abusers
  • •6\. Persons, who are obviously not compliant
  • •7\. Patients, who are employees at the investigational site, relative or spouse of the investigator
  • •8\. Acute and chronic inflammatory or infectious diseases (incl. target organ)
  • •9\. Advanced secondary changes at the target organ (e.g. emphysema or bronchiectasis)
  • •10\. Immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role

Outcomes

Primary Outcomes

Not specified

Similar Trials

Completed
Not Applicable
A multicenter, randomized controlled study of the clinical efficacy of intravenous peramivir versus oseltamivir against influenza A and B virus infection in high-risk patientsInfluenza virus infection
JPRN-UMIN000009479agasaki evaluation organization for clinical interventions120
Active, not recruiting
Phase 1
A multicentre, randomized, controlled study of the efficacy, safety and cost-effectiveness of a sequential therapy with RV4104A ointment, ciclopiroxolamine cream and ciclopirox film-forming solution compared with amorolfine nail lacquer alone for the treatment of dermatophytic onychomycosis (toenail) without matrix involvement - ONICO
EUCTR2009-011125-14-FRPierre Fabre Dermatologie260
Completed
Not Applicable
Internet-based relapse prevention for in-patients with anorexia nervosaSevere anorexia nervosa (AN)Mental and Behavioural DisordersEating disorders
ISRCTN18274621South London and Maudsley NHS Foundation Trust (UK)98
Active, not recruiting
Phase 3
Trial of sertraline to prevent post-traumatic brain injury depressioDepressive disorder after traumatic brain injuryMental and Behavioural Disorders
ISRCTN17518945King's College Hospital514
Completed
Not Applicable
The multicenter randomized controlled trial on the effect of Helicobacter pylori eradication for endoscopic gastric submucosal dissection (ESD) after artificial ulcer healingPatients have early gastric cancer endoscopic therapeutic indications lesions and adaptation expanding lesions, are Helicobacter pylori infection including the adenoma
JPRN-UMIN000015927Aichi Medical University130