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Completed

NCT Number: NCT01076803

Efficacy and Safety of Lanreotide 120 Milligram (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

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Key information

Conditions

Malignant Intestinal Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lanreotide (acetate)

Drug

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

Primary outcomes

  1. Percentage of responder patients.

    Time frame: At day 7 and day 14.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Feb 26, 2010
Registry last updated
Dec 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.