Phase III multicentre, Randomised, Double Blind, Comparative study to assess the efficacy and safety of lanreotide 30mg versus placebo as a palliative treatment of clinical symptoms associated with intestinal obstruction due to peritoneal carcinomatosis in inoperable patients

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2005-002349-38-NL
• Date of registration: 22/12/2006
• Prospective Registration: Yes
• Primary sponsor: Beaufour Ipsen Pharma-Ipsen Biotech Department
• Public title: Phase III multicentre, Randomised, Double Blind, Comparative study to assess the efficacy and safety of lanreotide 30mg versus placebo as a palliative treatment of clinical symptoms associated with intestinal obstruction due to peritoneal carcinomatosis in inoperable patients
• Scientific title: Phase III multicentre, Randomised, Double Blind, Comparative study to assess the efficacy and safety of lanreotide 30mg versus placebo as a palliative treatment of clinical symptoms associated with intestinal obstruction due to peritoneal carcinomatosis in inoperable patients
• Date of first enrolment: 26/02/2007
• Target sample size: 80
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002349-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Netherlands

Key inclusion & exclusion criteria

Inclusion criteria:
• Patient having given a written informed consent before completing any study-related procedure,
• Patient being over 18 years of age,
• Patient having a high digestive obstruction i.e. located on the upper part of the gastro-intestinal tract (stomach, duodenum, small bowel) ,
• Patient having a digestive obstruction of malignant origin1,
• Patient having peritoneal carcinomatosis confirmed by a CT Scan within the previous 3 months1,
• Patient having an obstruction with at least two vomiting episodes per day or the presence of a nasogastric suction tube1,
• Patient for whom surgery is inappropriate, either documented in the medical records or confirmed by a surgical advice within the previous 72 hours1,
• Patient being treated by intra-venous corticoids since at least 5 days and intra-venous proton pump inhibitors,
• Patient having an estimated survival of more than one month,
• Patient accepting to comply fully with the protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Patient having an operable obstruction1,
• Patient having a colic obstruction1 (must be documented by an abdominal X-Ray within the previous 3 days),
• Patient having received any specific anticancer therapy within the previous 15 days,
• Patient receiving any antiH2 receptor blockers1,
• Patient having a bowel obstruction which could be explained by a non malignant cause (hypokaliaemia, drug side-effects, renal insufficiency,..),
• Patient having signs of bowel perforation,
• Patient having received somatostatin or any analogue as treatment of the bowel obstruction,
• Patient having a contra-indication to intra-muscular injections,



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patient having a high digestive obstruction of malignant origin i.e. located on the upper part of the gastro-intestinal tract (stomach, duodenum, small bowel) for whom surgery is inappropriate.

Intervention(s)

Product Name: Somatuline PR 30mg
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: lanreotide
Other descriptive name: somatostatin analogue
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-mg
Pharmaceutical form of the placebo: Powder and solvent for suspension for injection
Route of administration of the placebo: Intramuscular use

Primary Outcome(s)

Secondary Objective: To assess the efficacy of lanreotide 30 mg as compared to placebo in terms of:
- vomiting improvement or decrease in the secretion volume sucked up by a nasogastric tube,
- nausea improvement,
- pain improvement,
- well-being improvement,
- symptom improvement delay,
- symptom improvement duration,
- concomitant medications consumption,
- hospitalisation duration.
To assess the clinical and biological safety of treatment.

Primary end point(s): Percentage of responder patients at D7.
A responder patient will be defined either as a patient experiencing one or less 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.
Number or vomiting episode or volume of daily drainage will be therefore recorded on each day from D0 (V1) to D7 (V3).

Main Objective: The primary objective of this study is to assess the efficacy of lanreotide 30 mg as compared to placebo to relieve clinical symptoms due to small bowel obstruction in inoperable patients with peritoneal carcinomatosis.

Secondary ID(s)

2-54-52030-156