Clinical Trial: Study to Assess Efficacy and Safety of Lanreotide Autogel 120 MG in Treatment of Clinical Symptoms Associated With Inoperable Malignant Intestinal Obstruction

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

Official Title: An International, Multicentric, Prospective, Open Label Study to Assess the Efficacy and Safety of Lanreotide Autogel 120 MG Associated to Standard of Care in the Treatment of Clinical Symptoms Associ

Brief Summary: To assess the efficacy of Lanreotide Autogel 120 mg for the relief of vomiting due to inoperable malignant intestinal obstruction in patients without nasogastric tube (NGT) and to assess the efficacy of lanreotide Autogel 120 mg on removal of nasogastric tube without the recurrence of vomiting in patients with an inoperable malignant intestinal obstruction with a nasogastric tube.

Detailed Summary:
Sponsor: Ipsen

Current Primary Outcome: Percentage of responding patients before or at Day 7 [ Time Frame: Up to Day 7 ]

Original Primary Outcome: Percentage of responding patients before or at Day 7 [ Time Frame: Up to Day 7 ]

Current Secondary Outcome:

• Percentage of responding patients before or at Day 14 [ Time Frame: Up to Day 14 ]
  A responder is defined as a patient experiencing ≤ 2 vomiting episodes/day during at least 3 consecutive days at any time point between the Day 0 and Day 14 or as a patient in whom the NGT has been removed during at least 3 consecutive days at any time point between the Day 0 and Day 14 without vomiting recurrence (as recorded on diary cards).
• Percentage of responding patients before or at Day 28 [ Time Frame: Up to Day 28 ]
  A responder is defined as a patient experiencing ≤ 2 vomiting episodes/day during at least 3 consecutive days at any time point between the Day 0 and Day 28 or as a patient in whom the NGT has been removed during at least 3 consecutive days at any time point between the Day 0 and Day 28 without vomiting recurrence (as recorded on diary cards).
• Change from baseline in Quality of Life [ Time Frame: Baseline, Days 7, 14 and 28 ]
  Quality of Life assessed by both patient and caregiver based on Edmonton Symptom Assessment System (ESAS). The ESAS scale is an 11-point scale ranging from 0 to 10 where zero [0] indicates no symptom and 10 indicates worst possible pain.
• Change from baseline in General activity [ Time Frame: Baseline, Days 7, 14 and 28 ]
  General activity assessed by Karnofsky performance score. Karnofsky performance score is used to quantify participant's general well-being and activities of daily life and participants are classified based on their functional impairment. Karnofsky performance scores range from 0 (death) to 100 (no evidence of disease).
• Number of daily episodes of nausea [ Time Frame: Baseline, Days 7, 14 and 28 ]
• Change from baseline in abdominal pain scores [ Time Frame: Baseline, Days 7, 14 and 28 ]
  Abdominal pain assessment using Visual Analogue Scale (VAS). The VAS is a 100-mm (10-cm) scoring scale. Score range on VAS is from 0 to 100 where zero [0] indicates no pain and 100 indicates worst possible pain.
• Change from baseline in average number of bowel movements per day [ Time Frame: Baseline, Days 7, 14 and 28 ]
  The passage of stools was an indicator of complete or incomplete bowel obstruction.

Original Secondary Outcome:

• Percentage of responding patients before or at Day 14 [ Time Frame: Up to Day 14 ]
  A responder is defined as a patient experiencing ≤ 2 vomiting episodes/day during at least 3 consecutive days at any time point between the Day 1 and Day 14 or as a patient in whom the NGT has been removed during at least 3 consecutive days at any time point between the Day 1 and Day 14 without vomiting recurrence (as recorded on diary cards).
• Percentage of responding patients before or at Day 28 [ Time Frame: Up to Day 28 ]
  A responder is defined as a patient experiencing ≤ 2 vomiting episodes/day during at least 3 consecutive days at any time point between the Day 1 and Day 28 or as a patient in whom the NGT has been removed during at least 3 consecutive days at any time point between the Day 1 and Day 28 without vomiting recurrence (as recorded on diary cards).
• Change from baseline in Quality of Life [ Time Frame: Baseline, Days 7, 14 and 28 ]
  Quality of Life assessed by both patient and caregiver based on Edmonton Symptom Assessment System (ESAS). The ESAS scale is an 11-point scale ranging from 0 to 10 where zero [0] indicates no symptom and 10 indicates worst possible pain.
• Change from baseline in General activity [ Time Frame: Baseline, Days 7, 14 and 28 ]
  General activity assessed by Karnofsky performance score. Karnofsky performance score is used to quantify participant's general well-being and activities of daily life and participants are classified based on their functional impairment. Karnofsky performance scores range from 0 (death) to 100 (no evidence of disease).
• Number of daily episodes of nausea [ Time Frame: Baseline, Days 7, 14 and 28 ]
• Change from baseline in abdominal pain scores [ Time Frame: Baseline, Days 7, 14 and 28 ]
  Abdominal pain assessment using Visual Analogue Scale (VAS). The VAS is a 100-mm (10-cm) scoring scale. Score range on VAS is from 0 to 100 where zero [0] indicates no pain and 100 indicates worst possible pain.
• Change from baseline in average number of bowel movements per day [ Time Frame: Baseline, Days 7, 14 and 28 ]
  The passage of stools was an indicator of complete or incomplete bowel obstruction.

Dates:
Date Received: October 23, 2014
Date Started: October 2014
Date Completion: December 2017
Last Updated: May 4, 2017
Last Verified: May 2017