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

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 - VAS score angio-edema attack

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON30040

Enrollment

Registered

2006-08-30

Start date

2006-09-01

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hereditairy angio-edema

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Descriptive research based on which the "minimally clinically significant difference" in symptomscore can be assessed.	—

Countries

Netherlands

Outcome results