drugset / Trial / NCT02365584

Quality of Life in Patients With Inoperable Malignant Bowel Obstruction

NCT02365584 ↗

Phase 2 Terminated 43 enrolled Ipsen
RandomizedParallel-groupOpen-labelSupportive care

Summary

The primary objective of the study is to evaluate the impact on quality of life of Lanreotide Autogel 120 mg in combination with standard care, in comparison to the standard care alone, in subjects affected by inoperable malignant bowel obstruction.

Timeline

Start
2015-01
Primary completion
2018-01-16
Completion
2018-01-16

Outcome

Missed primary endpoint

Stopped (Enrollment): “The study was terminated early due to insufficient recruitment.”

registry analysis (superiority test); Standard Care vs Standard Care + Lanreotide Autogel; p =0.5396; Adjusted LS Mean Difference -11 (95% CI -47 to 25); ANCOVA NCT02365584 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Lanreotide Other / unclassified 120 mg Subcutaneous