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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. (see Contacts and Locations)
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
  Purpose

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


Condition Intervention Phase
Malignant Intestinal Obstruction
Drug: Lanreotide (acetate)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Percentage of responder patients. [ Time Frame: At day 7 and day 14. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: October 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lanreotide (acetate) Drug: Lanreotide (acetate)
Deep subcutaneous injection into the upper external quadrant of the right or the left buttock.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01076803

Contacts
Contact: Karen Geboes, MD karen.geboes@ugent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Karen Geboes, MD       karen.geboes@ugent.be   
Principal Investigator: Karen Geboes, MD         
Sub-Investigator: Marc Peeters, MD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Karen Geboes, MD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01076803     History of Changes
Other Study ID Numbers: 2009/289
Study First Received: December 2, 2009
Last Updated: February 1, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
Malignant intestinal obstruction in inoperable patients

Additional relevant MeSH terms:
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Lanreotide
Angiopeptin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 11, 2014