Treatment of Idiopathic Pulmonary Fibrosis With Long Acting Octreotide

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00463983
• Date of registration: 18/04/2007
• Prospective Registration: No
• Primary sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Public title: Treatment of Idiopathic Pulmonary Fibrosis With Long Acting Octreotide FIBROSAND
• Scientific title: Phase 2 Study of Long Acting Octreotide in Idiopathic Pulmonary Fibrosis
• Date of first enrolment: October 2006
• Target sample size: 25
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00463983
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

France

Contacts

• Name: Bruno Crestani, MD, PhD
• Affiliation: INSERM, France

Key inclusion & exclusion criteria

Inclusion Criteria:

- confident diagnosis of IPF according to ATS/ERS criteria

Exclusion Criteria:

- known intolerance to somatostatin or octreotide

- another disease with predicted survival < 12 months

- pregnancy or lactation

- previous treatment with somatostatin or somatostatin analogs

- patient on a waiting list for transplantation

- antifibrotic treatment or prednisone > 10 mg/day within the last 6 weeks

- symptomatic biliary lithiasis

- blood coagulation disorders that prevent intra-muscular injections

- HIV infection

- hepatitis B or C active infection



Age minimum: 40 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: octreotide

Primary Outcome(s)

FVC changes [Time Frame: 12 months]

Secondary Outcome(s)

DLCO changes [Time Frame: 12 months]

Secondary ID(s)

C05-32

Source(s) of Monetary Support

Please refer to primary and secondary sponsors