COPE-trial: Colesevelam versus placebo in cholestatic pruritus, a double-blind placebo-controlled study

COPE-trial: Colesevelam versus placebo in cholestatic pruritus, a double-blind placebo-controlled study - Colesevelam versus placebo in cholestatic pruritus

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31774

Enrollment

Registered

2008-05-27

Start date

2008-09-10

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

cholestatic pruritus itch in cholestatic liver disease

Interventions

Treatment with effective agent (colesevelam) or placebo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: patients with pruritus as a result of a cholestatic disorder age above 18 informed consent

Exclusion criteria

Exclusion criteria: Use of cholestyramine Pregnancy Inability to understand or speak Dutch language Malignancy/Life expectancy

Design outcomes

Primary

Measure	Time frame
Primary endpoint: 40% reduction of pruritus according to visual analogue scores, comparison of mean VAS score on T=18,19,20 to mean VAS score on T=-2, -1, 0.	—

Secondary

Measure	Time frame
Secondary endpoints: Improvement in quality of life scores (T=0 compared to T=20) Reduction in pruritus score/scratch lesions (T=0 compared to T=20)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)