Study to estimate the minimum clinically different difference in visual analogue scale scores for skin swelling, skin pain and abdominal pain in subjects with hereditary angio-edema
- Conditions
- hereditairy angio-edema10021429
- Registration Number
- NL-OMON30040
- Lead Sponsor
- Jerini AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
Patients with documented type I or type II hereditary angio-edema (confirmed by medical history and C1-INH deficiency)
History of angio-edema attacks involving skin and/or abdomen
Male or Female
Age > 18 yrs
Signed written informed consent
Exclusion Criteria
Diagnosis of angio-edema other than HAE, e.g. acquired angio-edema
Patients participating in other trials
Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
Patients unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for follow-up, and unlikely to complete the study for any reason
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method