Clinical Trial: Quality of Life in Patients With Inoperable Malignant Bowel Obstruction

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase II, Multicentre, Randomized Controlled Study Evaluating The Quality Of Life In Patients With Inoperable Malignant Bowel Obstruction Treated With Lanreotide Autogel

Brief 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.

Detailed Summary:
Sponsor: Ipsen

Current Primary Outcome: Change from baseline of Mean AUC Edmonton Symptom Assessment System (ESAS) Total Scores. [ Time Frame: Day 7 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Single ESAS items symptom score. [ Time Frame: Baseline to day 7, day 14 and 28 ]
  • ESAS total score. [ Time Frame: Baseline to day 7, day 14 and 28 ]
  • Change from baseline in general activity. [ Time Frame: Baseline, day 7, 14 and 28 ]
    Karnofsky performance status
  • Change from baseline in abdominal pain scores. [ Time Frame: Baseline, day 7, 14 and 28 ]
    Visual analogue scale
  • In patients without nasogastric tube (NGT), the number of patients experiencing ≤ 2 vomiting episodes/day during at least 3 consecutive days. [ Time Frame: Between day 1 to 28 ]
  • In patients with NGT removed, the number of patients with at least 3 consecutive days without vomiting recurrence. [ Time Frame: Baseline, day 7, 14 and 28 ]
  • In patients with a NGT, change in daily NGT secretion volume. [ Time Frame: Baseline, day 7, 14 and 28 ]
  • Number of daily vomiting episodes and number of days without vomiting. [ Time Frame: Baseline, day 7, 14 and 28 ]
  • Change from baseline in average number of bowel movements per day. [ Time Frame: Baseline, day 7, 14 and 28 ]


Original Secondary Outcome: Same as current

Information By: Ipsen

Dates:
Date Received: January 29, 2015
Date Started: January 2015
Date Completion: January 2018
Last Updated: May 4, 2017
Last Verified: May 2017