Dumping SyndromePhase 4NCT00543179
Treatment of the Dumping Syndrome With Lanreotide Autogel®
A Phase 4 study testing Somatuline (Lanreotide Autogel®) in people with Dumping Syndrome, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Background Somatostatin and octreotide LAR (long-acting analogue) exert a number of inhibitory effects: on gut hormones, but also on gastro-intestinal secretion and motility. Somatostatin analogues are effective in preventing symptoms and signs of both early and late dumping as demonstrated previously. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dumping Syndrome
- What is being tested?
- Somatuline (Lanreotide Autogel®)
- How many people
- Not given
- Where
- 1 siteNetherlands
- Study dates
- Oct 2007to not given
- Phase
- Phase 4
- 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
- Patients with typical early dumping symptoms after gastric surgery are selected on the basis of the clinical diagnostic index devised by Sigstad. In addition their dumping score after an oral glucose challenge (dumping provocation test) is positive (1,2);
- Patients with late dumping are selected on the basis of a history suggestive of postprandial hypoglycaemia, a plasma glucose of less than 3.0 mm/l at least 60 min after ingestion of 50 g glucose/ m² body surface and hypoglycaemic symptoms at least 60 min after the oral glucose load;
- Patients will be on long term octreotide LAR therapy;
- Over 18 years of age;
- Written informed consent
Who cannot join
- patients with disorders of the endocrine system, patients with severe kidney, liver or cardiovascular disease;
- Current or planned pregnancy or lactation;
- Gastrointestinal surgery one year prior to inclusion;
- Other gastrointestinal diseases that might influence symptoms of the dumping syndrome.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
UMC St. Radboud Medical Center
Nijmegen, Gelderland, 6500 HB
Serena Slavenburg, MD, +31243617272, s.slavenburg@mdl.umcn.nl
About this study
Background Somatostatin and octreotide LAR (long-acting analogue) exert a number of inhibitory effects: on gut hormones, but also on gastro-intestinal secretion and motility.
Somatostatin analogues are effective in preventing symptoms and signs of both early and late dumping as demonstrated previously. However, octreotide LAR causes gastrointestinal side effects and the injection solution is difficult to prepare. Recently, a new somatostatin analogue with a prolonged release formulation, Lanreotide autogel (L-autogel), has become available. It is a viscous aqueous gel, composed solely of water and lanreotide. Deep subcutaneous administration may lead to increased treatment acceptance compared with intramuscular depot preparations. It is more easy to prepare and is though to cause less local side effects and technical problems than octreotide LAR. Recent studies have been done to measure the efficacy and safety of L-autogel in acromegalic treated previously with octreotide LAR. These studies showed that L-autogel is effective and well-tolerated in these patients, with equivalent or better disease control and less gastrointestinal adverse events. Until now, there is no data available on the effectivety of L-autogel in patients with a dumping syndrome. Therefore, this study aims to establish the effectiveness and tolerability of L-autogel in patients with a dumping syndrome, previously treated with octreotide LAR.
- Conditions
- Dumping Syndrome
- Being tested
- Somatuline (Lanreotide Autogel®)
- Medical subject headings
- Dumping Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatuline (Lanreotide Autogel®)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Responses to the dumping provocation test. Effectiveness is defined as a heart rate increase of ≤ 10 beats/min and a negative breath-hydrogen test after glucose provocation test.
Measured: baseline versus day 119
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2007 (estimated)
- Study startOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dumping SyndromeStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Jan BMJ Jansen, MD, PhD, Principal investigator, UMC. St. Radboud Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00543179
- Sponsor's protocol ID
- 2007/064
- Status last verified
- Oct 2007
- First submitted
- 11 Oct 2007
- Last updated
- 12 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of the Dumping Syndrome With Lanreotide Autogel®
- ClinicalTrials.gov ID
- NCT00543179
- Acronym / sponsor ID
- 2007/064
- Conditions
- Dumping Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Oct 2007
- First posted
- 12 Oct 2007 (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.
Background Somatostatin and octreotide LAR (long-acting analogue) exert a number of inhibitory effects: on gut hormones, but also on gastro-intestinal secretion and motility.
Somatostatin analogues are effective in preventing symptoms and signs of both early and late dumping as demonstrated previously. However, octreotide LAR causes gastrointestinal side effects and the injection solution is difficult to prepare. Recently, a new somatostatin analogue with a prolonged release formulation, Lanreotide autogel (L-autogel), has become available. It is a viscous aqueous gel, composed solely of water and lanreotide. Deep subcutaneous administration may lead to increased treatment acceptance compared with intramuscular depot preparations. It is more easy to prepare and is though to cause less local side effects and technical problems than octreotide LAR. Recent studies have been done to measure the efficacy and safety of L-autogel in acromegalic treated previously with octreotide LAR. These studies showed that L-autogel is effective and well-tolerated in these patients, with equivalent or better disease control and less gastrointestinal adverse events. Until now, there is no data available on the effectivety of L-autogel in patients with a dumping syndrome. Therefore, this study aims to establish the effectiveness and tolerability of L-autogel in patients with a dumping syndrome, previously treated with octreotide LAR.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with typical early dumping symptoms after gastric surgery are selected on the basis of the clinical diagnostic index devised by Sigstad. In addition their dumping score after an oral glucose challenge (dumping provocation test) is positive (1,2);
- Patients with late dumping are selected on the basis of a history suggestive of postprandial hypoglycaemia, a plasma glucose of less than 3.0 mm/l at least 60 min after ingestion of 50 g glucose/ m² body surface and hypoglycaemic symptoms at least 60 min after the oral glucose load;
- Patients will be on long term octreotide LAR therapy;
- Over 18 years of age;
- Written informed consent
Key exclusion criteria (4 listed)
- patients with disorders of the endocrine system, patients with severe kidney, liver or cardiovascular disease;
- Current or planned pregnancy or lactation;
- Gastrointestinal surgery one year prior to inclusion;
- Other gastrointestinal diseases that might influence symptoms of the dumping syndrome.
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 |
|---|---|---|
| Somatuline (Lanreotide Autogel®) | Drug | – |
Primary outcome
Responses to the dumping provocation test. Effectiveness is defined as a heart rate increase of ≤ 10 beats/min and a negative breath-hydrogen test after glucose provocation test.
Time frame: baseline versus day 119
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2007.
Related trials for Dumping Syndrome
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Dumping Syndrome After Esophagectomy
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Continuous Glucose Monitoring With iCan i3 in Post-Bariatric Patients With Late Dumping Syndrome
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Dumping Syndrome and Esophageal Atresia
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Comparing Dumping Symptoms and Quality of Life 6 Months After Sleeve Gastrectomy With or Without Transit Bipartition in Adults With Obesity
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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.
Jan BMJ Jansen, MD, PhD principal investigator
UMC. St. Radboud Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Somatuline (Lanreotide Autogel®) in people with Dumping Syndrome, run by Radboud University Medical Center at 1 site in Netherlands.
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 4 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: status not confirmed, as of the sponsor's last update on 12 Oct 2007. 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 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serena Slavenburg, MD (+31243617272, s.slavenburg@mdl.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responses to the dumping provocation test. Effectiveness is defined as a heart rate increase of ≤ 10 beats/min and a negative breath-hydrogen test after glucose provocation test. (time frame: baseline versus day 119). 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 12 Oct 2007.