Malignant Intestinal ObstructionPhase 2NCT01076803
Efficacy and Safety of Lanreotide 120 Milligram (mg) as a Palliative Treatment of Clinical Symptoms Associated With Malignant Intestinal Obstruction in Inoperable Patients
A Phase 2 study testing Lanreotide (acetate) in people with Malignant Intestinal Obstruction, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Intestinal Obstruction
- What is being tested?
- Lanreotide (acetate)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2009to Jul 2013
- Phase
- Phase 2
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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)
Read more
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
- Conditions
- Malignant Intestinal Obstruction
- Being tested
- Lanreotide (acetate)
- Keywords
- Malignant intestinal obstruction in inoperable patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lanreotide (acetate)Drug
Deep subcutaneous injection into the upper external quadrant of the right or the left buttock.
| Study group | Role | What they receive |
|---|---|---|
| Lanreotide (acetate) | Experimental | Not described Receives: Drug: Lanreotide (acetate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of responder patients.
Measured: At day 7 and day 14.
Secondary outcomes (7)
Number of daily vomiting episodes on diary cards or measurements of the daily drainage by naso gastric tube (NGT).
Measured: day 7, day 14 and day 28 after administration of Lanreotide
Number of days without vomiting episodes
Measured: day 7, day 14 and day 28 after administration of Lanreotide
Number of daily nausea episodes recorded on diary cards.
Measured: day 7, day 14 and day 28 after administration of Lanreotide
Intensity of abdominal pain assessed on a visual analogue scale.
Measured: day 7, day 14 and day 28 after administration of Lanreotide.
Well-being assessed on a visual analogue scale.
Measured: day 7, day 14 and day 28 after administration of Lanreotide.
Time between first injection and clinical response.
Measured: day 7, day 14 and day 28 after administration of Lanreotide
Clinical and biological adverse events.
Measured: day 7, day 14 and day 28 after administration of Lanreotide.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startOct 2009
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Intestinal ObstructionStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Geboes, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076803
- Sponsor's protocol ID
- 2009/289
- Status last verified
- Dec 2014
- First submitted
- 2 Dec 2009
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01076803
- Acronym / sponsor ID
- 2009/289
- Conditions
- Malignant Intestinal Obstruction
- Keywords
- Malignant intestinal obstruction in inoperable patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 26 Feb 2010 (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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lanreotide (acetate) | Experimental | Drug: Lanreotide (acetate) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 (acetate)Deep subcutaneous injection into the upper external quadrant of the right or the left buttock. | Drug | Lanreotide (acetate) |
Primary outcome
Percentage of responder patients.
Time frame: At day 7 and day 14.
7 secondary outcomes
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
Number of days without vomiting episodes
Time frame: day 7, day 14 and day 28 after administration of Lanreotide
Number of daily nausea episodes recorded on diary cards.
Time frame: day 7, day 14 and day 28 after administration of Lanreotide
Intensity of abdominal pain assessed on a visual analogue scale.
Time frame: day 7, day 14 and day 28 after administration of Lanreotide.
Well-being assessed on a visual analogue scale.
Time frame: day 7, day 14 and day 28 after administration of Lanreotide.
Time between first injection and clinical response.
Time frame: day 7, day 14 and day 28 after administration of Lanreotide
Clinical and biological adverse events.
Time frame: day 7, day 14 and day 28 after administration of Lanreotide.
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 Dec 2014.
- website of the University Hospital GhentLink provided by the sponsor.
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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.
Karen Geboes, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lanreotide (acetate) in people with Malignant Intestinal Obstruction, run by University Hospital, Ghent at 1 site in Belgium.
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 6 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 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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. (time frame: At day 7 and day 14.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2014; AzTrials last refreshed its copy on 8 Nov 2026.