Intestinal ObstructionPhase 3NCT00216372
Efficacy and Safety of Lanreotide Microparticles as Palliative Treatment in Peritoneal Carcinomatosis
A Phase 3 study testing Lanreotide (microparticle formulation) in people with Intestinal Obstruction and Carcinoma, run by Ipsen at 53 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestinal Obstruction, Carcinoma, Peritoneal Neoplasms
- What is being tested?
- Lanreotide (microparticle formulation)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 53 sitesin 3 countries
- Study dates
- Sep 2003to Oct 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- specific anticancer therapy within the previous 15 days
- signs of bowel perforation
- somatostatin or any analogue as treatment of the bowel obstruction
Trial locations and contacts
53 sites in 3 countries.
53 sites in 3 countries
France48 sites
Hôpital Nord
Amiens
Clinique de l'Anjou
Angers
Hôtel-Dieu
Angers
CH Victor Dupouy
Argenteuil, 95100
Hôpital Saint André
Bordeaux, 33075
Hôpital de la Cavale Blanche
Brest, 29609
Centre François Baclesse
Caen
Hôpital Nord
Cébazat, 63118
Clinique de l'Amandier
Châtenay-Malabry
Hôpital Hôtel-Dieu
Clermont-Ferrand
Hôpital Beaujon
Clichy, 92118
Hôpital Pasteur
Colmar
Centre Hospitalier de Compiègne
Compiègne, 60321
Hôpital Henri Mondor
Créteil, 94000
Centre Hospitalier Victor Jousselin
Dreux, 28102
Clinique Sainte Marguerite
Hyères
Centre Hospitalier Départemental
La Roche-sur-Yon
Hôpital André Mignot
Le Chesnay, 78150
Hôpital Notre-Dame du Perpétuel Secours
Levallois-Perret, 92309
CHU Dupuytren
Limoges, 87042
Hôpital Site de Lorient
Lorient
Hôpital de la Croix Rousse
Lyon
Hôpital de l'Archet 2
Nice
Hôpital de la Source
Orléans
Centre de Radiothérapie et Oncologie Médicale
Osny
Hôpital du Val de Grâce
Paris, 75005
Institue Curie
Paris, 75005
Hôpital des Diaconesses
Paris, 75012
Hôpital Saint Antoine
Paris, 75012
Hôtel Dieu
Paris, 75181
Hôpital Pitié Salpêtrière
Paris, 75651
Hôpital Georges Pompidou
Paris
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Institut Jean Godinot
Reims
Centre Eugène Marquis
Rennes
Centre Hospitalier de Roanne
Roanne
CAC Becquerel
Rouen, 76038
Hôpital Charles Nicolle
Rouen
Clinique Armoricaine de Radiologie
Saint-Brieuc, 22015
Clinique Guillaume de Varye
Saint-Doulchard
Institut de Cancérologie de la Loire
Saint-Etienne, 42020
Centre Hospitalier Gaston Ramon
Sens, 89108
Hôpital Civil
Strasbourg, 67091
Hôpital Hautepierre
Strasbourg
C.H.R. de Metz-Thionville
Thionville, 57126
Hôpital de Rangueil
Toulouse
Hôpital Joseph Ducuing
Toulouse
Institut Gustave Roussy
Villejuif
Belgium4 sites
Clinique Universitaire St. LUC
Brussels
Institut Jules Bordet
Brussels
Clinique Notre-Dame
Hermalle-sous-Huy
Centre Hospitalier de Jolimont-Lobbes
La Louvière
About this study
Official title: Phase III, Multicentre, Randomised, Double-blind, Comparative Study to Assess the Efficacy and Safety of Lanreotide 30 mg Versus Placebo as a Palliative Treatment of Clinical Symptoms Associated With Intestinal Obstruction Due to Peritoneal Carcinomatosis in Inoperable Patients.
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.
- Conditions
- Intestinal Obstruction, Carcinoma, Peritoneal Neoplasms
- Being tested
- Lanreotide (microparticle formulation), Placebo
- Keywords
- carcinomatosis
- Medical subject headings
- Intestinal Obstruction, Carcinoma, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lanreotide (microparticle formulation)Drug
A single 30 mg intra-muscular injection on day 0. The duration of the blinded phase is 10 days. Patients may enter the open phase where they receive 30 mg intra-muscular injections, every 10 days until investigator/or patient decide to stop treatment.
PlaceboOther
A single intra-muscular injection on day 0.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Lanreotide (microparticle formulation) |
| 2 | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: Daily for the duration of the study
Number of days with no vomiting episodes
Measured: For the duration of the study
Number of daily nausea episodes
Measured: Daily for the duration of the study
Intensity of abdominal pain
Measured: Daily for the duration of the study
Well-being
Measured: Daily for the duration of the study
Symptom relief duration
Measured: Between the first day of clinical response and the end of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intestinal ObstructionStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216372
- Sponsor's protocol ID
- 2-54-52030-156 (408)
- Other IDs
- 2005-002349-38, 2005
- Status last verified
- Nov 2020
- First submitted
- 13 Sep 2005
- Last updated
- 5 Nov 2020
- Results posted
- No
Publications
Mariani P, Blumberg J, Landau A, Lebrun-Jezekova D, Botton E, Beatrix O, Mayeur D, Herve R, Maisonobe P, Chauvenet L. Symptomatic treatment with lanreotide microparticles in inoperable bowel obstruction resulting from peritoneal carcinomatosis: a randomized, double-blind, placebo-controlled phase III study. J Clin Oncol. 2012 Dec 10;30(35):4337-43. doi: 10.1200/JCO.2011.40.5712. Epub 2012 Oct 29.
PubMed 23109694
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Multicentre, Randomised, Double-blind, Comparative Study to Assess the Efficacy and Safety of Lanreotide 30 mg Versus Placebo as a Palliative Treatment of Clinical Symptoms Associated With Intestinal Obstruction Due to Peritoneal Carcinomatosis in Inoperable Patients.
- ClinicalTrials.gov ID
- NCT00216372
- Acronym / sponsor ID
- 2-54-52030-156 (408)
- Conditions
- Intestinal Obstruction, Carcinoma, Peritoneal Neoplasms
- Keywords
- carcinomatosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Lanreotide (microparticle formulation) |
| 2 | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- specific anticancer therapy within the previous 15 days
- signs of bowel perforation
- somatostatin or any analogue as treatment of the bowel obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lanreotide (microparticle formulation)A single 30 mg intra-muscular injection on day 0. The duration of the blinded phase is 10 days. Patients may enter the open phase where they receive 30 mg intra-muscular injections, every 10 days until investigator/or patient decide to stop treatment. | Drug | 1 |
| PlaceboA single intra-muscular injection on day 0. | Other | 2 |
Primary outcome
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
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Derived from this study: PubMed 23109694Mariani P, Blumberg J, Landau A, Lebrun-Jezekova D, Botton E, Beatrix O, Mayeur D, Herve R, Maisonobe P, Chauvenet L. Symptomatic treatment with lanreotide microparticles in inoperable bowel obstruction resulting from peritoneal carcinomatosis: a randomized, double-blind, placebo-controlled phase III study. J Clin Oncol. 2012 Dec 10;30(35):4337-43. doi: 10.1200/JCO.2011.40.5712. Epub 2012 Oct 29.
Related trials for Intestinal Obstruction
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Active, not recruiting
Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients
Central Line Complication, Central Line-associated Bloodstream Infection (CLABSI)
Enrolling by invitationObservational study
Intestinal Obstruction Surgery. Acute Abdominal Pathology. №9:05/05/2026
Small Bowel Adhesion, Obstruction Bowel
Recruiting
Rectus Sheath Catheters Following Midline Laparotomy
Acute Abdomen, Ileus
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
53 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lanreotide (microparticle formulation) in people with Intestinal Obstruction and Carcinoma, run by Ipsen at 53 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in France, Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00216372, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.