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

NCT01076803 | Completed Phase 2

• 1 other identifier: 2009/289
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Malignant Intestinal Obstruction

Keywords

Malignant intestinal obstruction in inoperable patients

Outcome Measures

Primary Outcomes (1)

• Percentage of responder patients.

  At day 7 and day 14.

Secondary Outcomes (7)

• Number of daily vomiting episodes on diary cards or measurements of the daily drainage by naso gastric tube (NGT).

  day 7, day 14 and day 28 after administration of Lanreotide

• Number of days without vomiting episodes

  day 7, day 14 and day 28 after administration of Lanreotide

• Number of daily nausea episodes recorded on diary cards.

  day 7, day 14 and day 28 after administration of Lanreotide

• Intensity of abdominal pain assessed on a visual analogue scale.

  day 7, day 14 and day 28 after administration of Lanreotide.

• Well-being assessed on a visual analogue scale.

  day 7, day 14 and day 28 after administration of Lanreotide.

Study Arms (1)

Lanreotide (acetate)

EXPERIMENTAL

Drug: Lanreotide (acetate)

Interventions

Lanreotide (acetate) DRUG

Deep subcutaneous injection into the upper external quadrant of the right or the left buttock.

Lanreotide (acetate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

• website of the University Hospital Ghent

MeSH Terms

Interventions

lanreotide

Study Officials

• Karen Geboes, MD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2009
• First Posted: February 26, 2010
• Study Start: October 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 5, 2014

Record last verified: 2014-12

Locations

BE (1)