Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01076803
Recruitment Status : Completed
First Posted : February 26, 2010
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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


Condition or disease Intervention/treatment Phase
Malignant Intestinal Obstruction Drug: Lanreotide (acetate) Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2009
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Lanreotide (acetate) Drug: Lanreotide (acetate)
Deep subcutaneous injection into the upper external quadrant of the right or the left buttock.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Percentage of responder patients. [ Time Frame: At day 7 and day 14. ]

Secondary Outcome Measures :
  1. 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 ]
  2. Number of days without vomiting episodes [ Time Frame: day 7, day 14 and day 28 after administration of Lanreotide ]
  3. Number of daily nausea episodes recorded on diary cards. [ Time Frame: day 7, day 14 and day 28 after administration of Lanreotide ]
  4. Intensity of abdominal pain assessed on a visual analogue scale. [ Time Frame: day 7, day 14 and day 28 after administration of Lanreotide. ]
  5. Well-being assessed on a visual analogue scale. [ Time Frame: day 7, day 14 and day 28 after administration of Lanreotide. ]
  6. Time between first injection and clinical response. [ Time Frame: day 7, day 14 and day 28 after administration of Lanreotide ]
  7. Clinical and biological adverse events. [ Time Frame: day 7, day 14 and day 28 after administration of Lanreotide. ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076803


Locations
Layout table for location information
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Layout table for investigator information
Principal Investigator: Karen Geboes, MD University Hospital, Ghent
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01076803    
Other Study ID Numbers: 2009/289
First Posted: February 26, 2010    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014
Keywords provided by University Hospital, Ghent:
Malignant intestinal obstruction in inoperable patients
Additional relevant MeSH terms:
Layout table for MeSH terms
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Lanreotide
Angiopeptin
Antineoplastic Agents