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Anti-inflammatory pulmonal therapy of CF-patients with Amitriptyline and Placebo

Anti-inflammatory pulmonal therapy of CF-patients with Amitriptyline and Placebo

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-002673-13-DE
Enrollment
Unknown
Registered
2008-08-27
Start date
Unknown
Completion date
Unknown
Last updated
2022-01-04

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

Conditions

Deficiency of the Cftr-molecule results in accumulation of ceramide in respiratory epithelial cells. Ceramide triggers a pro-inflammatory and -apoptotic status in cystic fibrosis patients. Amitriptyline reduces ceramide levels in the lung tissue, normalises the activity of cytokines and prevents constitutive cell death of epithelial cells. Amitriptyline prevents pulmonary infections of CF-mice with P. aeruginosa. Amitriptyline may result in an improved lung function of cystic fibrosis patients.

Interventions

Trade Name: Amitriptylin-CT Product Name: Amitriptyline Pharmaceutical Form: Capsule* INN or Proposed INN: Amitriptyline CAS Number: 50486 Current Sponsor code: Amitriptyline Concentration unit: mg mi

Sponsors

PSKS
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026