Efficacy and Safety of Lanreotide 120 Milligram (mg) as a Palliative Treatment of Clinical Symptoms Associated With Malignant Intestinal Obstruction in Inoperable Patients

This study is currently recruiting participants.
Verified February 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01076803
First received: December 2, 2009
Last updated: February 1, 2013
Last verified: February 2013

December 2, 2009
February 1, 2013
October 2009
July 2013   (final data collection date for primary outcome measure)
Percentage of responder patients. [ Time Frame: At day 7 and day 14. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01076803 on ClinicalTrials.gov Archive Site
  • Number of daily vomiting episodes on diary cards or measurements of the daily drainage by naso gastric tube (NGT). [ Time Frame: day 7, day 14 and day 28 after administration of Lanreotide ] [ Designated as safety issue: No ]
  • Number of days without vomiting episodes [ Time Frame: day 7, day 14 and day 28 after administration of Lanreotide ] [ Designated as safety issue: No ]
  • Number of daily nausea episodes recorded on diary cards. [ Time Frame: day 7, day 14 and day 28 after administration of Lanreotide ] [ Designated as safety issue: No ]
  • Intensity of abdominal pain assessed on a visual analogue scale. [ Time Frame: day 7, day 14 and day 28 after administration of Lanreotide. ] [ Designated as safety issue: No ]
  • Well-being assessed on a visual analogue scale. [ Time Frame: day 7, day 14 and day 28 after administration of Lanreotide. ] [ Designated as safety issue: No ]
  • Time between first injection and clinical response. [ Time Frame: day 7, day 14 and day 28 after administration of Lanreotide ] [ Designated as safety issue: No ]
  • Clinical and biological adverse events. [ Time Frame: day 7, day 14 and day 28 after administration of Lanreotide. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Lanreotide 120 Milligram (mg) as a Palliative Treatment of Clinical Symptoms Associated With Malignant Intestinal Obstruction in Inoperable Patients
Prospective Study to Assess the Efficacy and Safety of Lanreotide 120 mg as a Palliative Treatment of Clinical Symptoms Associated With Malignant Intestinal Obstruction in Inoperable Patients

The primary objective of this study is to assess the efficacy of Lanreotide 120 mg for the relief of clinical symptoms due to malignant bowel obstruction in inoperable patients. This effect will be evaluated by the percentage of responder patients 7 and 14 days after one administration of lanreotide 120 mg.

(A responder patient will be defined either as a patient experiencing < or= 1 vomiting episode per day during at least three consecutive days or as a patient in whom NGT has been removed without any vomiting recurrence during at least three consecutive days)

The total number of visits will depend on the clinical situation, 5 visits are obligatory: Day(D)-3/-0,Day 1,Day 7,Day 14,Day 28

Inclusion visit (D-3/-0): eligibility, PIC, obstruction history, clinical exam, vital signs, diary cards, VAS scale, cc medication, blood sample

Visit D1: injection Visit D7/D14/28: clinical exam, nutrition procedure, result of biochemical analyse, adverse events, cc medication

In between the visits, the patient will keep and fill out his diary and VAS scale

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Intestinal Obstruction
Drug: Lanreotide (acetate)
Deep subcutaneous injection into the upper external quadrant of the right or the left buttock.
Experimental: Lanreotide (acetate)
Intervention: Drug: Lanreotide (acetate)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
July 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • PIC
  • >= 18 years at time of enrolment
  • Diagnosis of a digestive obstruction of malignant origin
  • Diagnosis of peritoneal carcinomatosis confirmed by a ct scan within the previous 3 months
  • Inoperability as decided after surgical consultation

Exclusion Criteria:

  • Operable obstruction
  • Bowel obstruction that can be explained by a non malignant cause
  • Signs of bowel obstruction
  • Prior treatment with somatostatin analogues within the previous 60 days
  • Known hypersensitivity to any of the test materials or related compounds
  • Previous enrolment in this study
Both
18 Years and older
No
Contact: Karen Geboes, MD karen.geboes@ugent.be
Belgium
 
NCT01076803
2009/289
No
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Karen Geboes, MD University Hospital, Ghent
University Hospital, Ghent
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP