Trial · Interventional

CompletedPhase 3Registry data

Efficacy and Safety of Lanreotide Microparticles as Palliative Treatment in Peritoneal Carcinomatosis

NCTNCT00216372Other id2-54-52030-156 (408)Other id2005-002349-38Other id2005

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 80 participants (actual)
Sponsor: Ipsen · Industry
Design: Randomized · Double masking
Countries: 3 countries
Belgium, France, Netherlands
Start: Sept 2003
Primary completion: Oct 2008
Completion: Oct 2008
First posted: 22 Sept 2005 (estimated)
Last update posted: 5 Nov 2020
Conditions: Intestinal Obstruction · Carcinoma · Peritoneal Neoplasms

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2003200420052006200720082009

Ph 3
Efficacy and Safety of Lanreotide Microparticles as Palliative Treatment in Peritoneal Carcinomatosis
NCT00216372
Sept 2003 to Oct 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to determine whether lanreotide 30mg microparticles are effective in the relief of clinical symptoms due to small bowel obstruction in inoperable patients with peritoneal carcinomatosis.

Interventions

Lanreotide (microparticle formulation)Drug
PlaceboOther

Arms2

Experimental
1
Placebo comparator
2

Primary outcomes1

Outcomes the sponsor listed as primary.

Percentage of responder patients (patient with 1 or less vomiting episode per day during at least 3 consecutive days or in whom nasogastric tube (NGT) has been removed during at least three consecutive days without vomiting recurrence)
Time frame · On day 7 (plus 1 day at the latest) after the first injection

Secondary outcomes(6)

Number of daily vomiting episodes or measurement of the daily drainage by NGT
Time frame · Daily for the duration of the study
Number of days with no vomiting episodes
Time frame · For the duration of the study
Number of daily nausea episodes
Time frame · Daily for the duration of the study
Intensity of abdominal pain
Time frame · Daily for the duration of the study
Well-being
Time frame · Daily for the duration of the study
Symptom relief duration
Time frame · Between the first day of clinical response and the end of follow-up

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2012

6 results

Symptomatic treatment with lanreotide microparticles in inoperable bowel obstruction resulting from peritoneal carcinomatosis: a randomized, double-blind, placebo-controlled phase III study.

Mariani et al. 2012Journal of clinical oncology : official journal of the American Society of Clinical Oncologycited by 38

PMID 23109694DOI 10.1200/jco.2011.40.5712PUB-23109694

Rights unknown6 results

Source link See results (6)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * digestive obstruction located in the upper part of the gastro-intestinal tract * digestive obstruction of malignant origin * peritoneal carcinomatosis confirmed by a CT Scan * at least two vomiting episodes per day or a presence of a nasogastric suction tube * inoperable patients Exclusion Criteria: * specific anticancer therapy within the previous 15 days * signs of bowel perforation * somatostatin or any analogue as treatment of the bowel obstruction

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