Dumping SyndromePhase 2NCT01923649
SOMATULINE Autogel 90 mg IN DUMPING SYNDROME
A Phase 2 study testing Lanreotide 90 mg slow release formulation in people with Dumping Syndrome, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in Belgium.
Trial summary
The purpose of this study is to assess if Somatuline autogel 90 mg is effective in the treatment of dumping syndrome. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Dumping Syndrome
- What is being tested?
- Lanreotide 90 mg slow release formulation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 3 sitesBelgium
- Study dates
- Apr 2008to 2 Dec 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinical suspect of a dumping syndrome with a total dumping score* (early and late symptoms) ≥ 10, and
- a positive OGTT, in terms of a glycemia <60 mg/dl or Hematocrit increase > 3%, or an increase of pulse rate by 10 bpm Or
- documented spontaneous hypoglycemia (at least 1)
- Age > 18 years
- Diet of 6 meals a day with low concentration of mono- and disaccharides during 1 month before inclusion without sufficient improvement (= evaluation by physician and patient)
Who cannot join
- Patients who have been treated with Somatuline or Sandostatine LAR in the past
- Cholecystolithiasis
- Diabetes Mellitus
- Coeliakie and Giardia
- Untreated severe oesophagitis
- Untreated gastric and duodenum ulcer
- Patients who are: (a) pregnant, (b) breast feeding, (c) of childbearing potential without a negative pregnancy test prior to Study Day 1, and (d) female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial (postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential).
- Hypersensitivity to lanreotide or one of the compounds of the drug.
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
AZ St. Lucas
Brugges, 8310
ZOL Genk
Genk, 3600
University Hospitals Leuven
Leuven, 3000
About this study
The purpose of this study is to assess if Somatuline autogel 90 mg is effective in the treatment of dumping syndrome.
Read the detailed description
Dumping syndrome has characteristic alimentary and systemic manifestations. It is one of the most common postprandial syndromes observed after extensive gastric surgery. Dumping syndrome can be separated into an early and late phase depending on the occurrence of symptoms in relation to the time elapsed after a meal. The early phase occurs because of rapid delivery of large amounts of osmotic active solids and liquids into the duodenum. The late phase is caused by a rapid increase of the glycemia and insuline causing hypoglycemia when the nutrients are not available any more. Dumping syndrome is the direct result of alterations in the storage function of the stomach and/or the pyloric emptying mechanism.
Incidence and severity of symptoms in dumping syndrome are related directly to the extent of gastric surgery. An estimated 25-50% of all patients who have undergone gastric surgery have some symptoms of dumping. Only 1-5% are reported to have severe disabling symptoms. Incidence of significant dumping has been reported to be 6-14% in patients after truncal vagotomy and drainage and from 14-20% in patients after partial gastrectomy. Incidence of dumping syndrome after proximal gastric vagotomy without any drainage procedure is less than 2%. In the pediatric population, dumping syndrome is described in children who have undergone Nissen fundoplication.
Several treatments can be proposed to a patient with dumping. Initially a diet of several small meals with a low concentration of mono-and disaccharides is prescribed and the patient is asked to avoid liquids during a meal. Several medical treatments can be utilized as guar gum, to increase the viscosity and reduce gastric emptying; pectine, to avoid a late hypoglycemia; acarbose, to block the digestion of saccharides. Some of them have only a partial effect or important side effects.
Surgical interventions like an interposition of an antiperistaltic jejunal segment will reduce the intestinal motility or a Roux-en-Y construction can be created. These surgical interventions are sometimes necessary but remain quite invasive and not always useful.
Somatostatin analogues have been used with success in patients with dumping syndrome. They exert a strong inhibitory effect on the release of insulin and several gut-derived hormones. The effectiveness of analogues in controlling the symptoms of both early and late dumping has been demonstrated in several randomized control trials. Somatostatin analogues interfere with the pathophysiology of a dumping syndrome in several ways. Somatostatin analogues reduce the secretion of insulin and prevents the occurrence of a late hypoglycaemia; decrease the concentration of different hormones responsible for the vaso-dilatation and the activation of the renin-angiotensine system that is seen in the early faze of the dumping syndrome. Somatostatin has also an effect on gastric motility and transit time.
One of the main problems is the high cost and daily subcutaneous administration of somatostatin analogues .
Somatuline® Autogel is a slow-release formulation that requires only monthly injection and supply high-dose, stable serum levels of lanreotide. These agents provide improved patient compliance since they are administered on a monthly schedule.
The purpose of this study is to assess if Somatuline autogel 90 mg is effective in the treatment of dumping syndrome. This will be a 27 weeks double blinded placebo-controlled cross-over multicenter study assessing the effect of Somatuline 90 mg in patients with dumping syndrome.
Reports on the therapeutic effectiveness of lanreotide in the management of dumping symptoms are scarce and based on small numbers of patients. Data on the effect of lanreotide in the treatment of dumping are missing. In this trial, all patients will be treated with Somatuline ® Autogel 90 mg. From a pharmacokinetic point of view, all patients will have reached steady state concentration of lanreotide after 12 weeks of treatment. After 12 weeks, a wash-out period of 4 weeks is inserted before patients will be crossed over to placebo or active treatment at week 16.
- Conditions
- Dumping Syndrome
- Being tested
- Lanreotide 90 mg slow release formulation, Placebo
- Keywords
- postoperative dumping, somatostatin analogues, somatulin, lanreotide, dumping syndrome
- Medical subject headings
- Dumping Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lanreotide 90 mg slow release formulationDrug
Also called Somatulin autogel
Lanreotide 90 mg slow release formulation is injected deep subcutaneously, every 4 weeks, three times and compared to placebo
PlaceboDrug
Placebo for somatuline slow release 90 mg
| Study group | Role | What they receive |
|---|---|---|
| Lanreotide slow release 90 mg | Experimental | Patients receive lanreatide slow release (Somatuline autogel) 90 mg every four weeks via a deep subcutaneous injection, three times. After a wash out period of 4 weeks they receive a similar placebo every for weeks, three times. Receives: Drug: Lanreotide 90 mg slow release formulation |
| Placebo | Placebo comparator | Patients receive a deep subcutanous injection of placebo every four weeks, three times. After a wash out of three weeks, they will receive somatuline 90 mh via a deep subcutanous injection every four weeks, three times. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Total Dumping score after treatment with Somatuline 90 mg and after placebo.
Early dumping starts immediately after a meal, within 1 hour (< 1 hour). Late dumping starts later than 1 hour after a meal (≥ 1 hour). Each item is scored from zero (not present) 1 (mild) , 2 (moderate) and 3 (severe). Early dumping symptoms : sweating, flushes, dizziness, palpitations, abdominal pain, diarrhea, bloating, nausea. Late dumping symptoms : sweating, palpitations, hunger, drowsiness to unconsciousness, shaking and aggression.
The change in dumping score will be assessed after 11 weeks and a second time after cross over at week 27.
Additionally, the overall improvement is assessed by asking "how do you feel compared with your situation before starting the study at week 11. The same question is asked at week 27. Additionally at week 27 the following question is asked " How do you feel compared with your situation 4 months ago ?" Scoring is done on a 7 point Likert scale.
Measured: at week 11 and week 27 during the study
Secondary outcomes (2)
Change in quality of life.
To assess the effect of Somatuline 90 mg versus placebo on a standardized quality of life questionnaire (QOL SF-36).
Measured: week 0, 11, 16 and 27
The difference in number of participants with adverse events between somatuline 90 mg versus placebo
To assess the tolerability of Somatuline 90 mg versus placebo.
Measured: at week 27 (end of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2013 (estimated)
- Study startApr 2008
- Primary completion2 Dec 2013
- Study completion2 Dec 2013
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 Universitaire Ziekenhuizen KU LeuvenThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Ipsen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923649
- Sponsor's protocol ID
- S50966
- Other IDs
- 2008-000643-34, 2008
- Status last verified
- Jul 2017
- First submitted
- 19 Jul 2013
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOMATULINE Autogel 90 mg IN DUMPING SYNDROME
- ClinicalTrials.gov ID
- NCT01923649
- Acronym / sponsor ID
- S50966
- Conditions
- Dumping Syndrome
- Keywords
- postoperative dumping, somatostatin analogues, somatulin, lanreotide, dumping syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Ipsen
- Study start
- Apr 2008
- Primary completion
- 2 Dec 2013 (actual)
- Study completion
- 2 Dec 2013 (actual)
- First posted
- 15 Aug 2013 (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 assess if Somatuline autogel 90 mg is effective in the treatment of dumping syndrome.
Detailed description
Dumping syndrome has characteristic alimentary and systemic manifestations. It is one of the most common postprandial syndromes observed after extensive gastric surgery. Dumping syndrome can be separated into an early and late phase depending on the occurrence of symptoms in relation to the time elapsed after a meal. The early phase occurs because of rapid delivery of large amounts of osmotic active solids and liquids into the duodenum. The late phase is caused by a rapid increase of the glycemia and insuline causing hypoglycemia when the nutrients are not available any more. Dumping syndrome is the direct result of alterations in the storage function of the stomach and/or the pyloric emptying mechanism.
Incidence and severity of symptoms in dumping syndrome are related directly to the extent of gastric surgery. An estimated 25-50% of all patients who have undergone gastric surgery have some symptoms of dumping. Only 1-5% are reported to have severe disabling symptoms. Incidence of significant dumping has been reported to be 6-14% in patients after truncal vagotomy and drainage and from 14-20% in patients after partial gastrectomy. Incidence of dumping syndrome after proximal gastric vagotomy without any drainage procedure is less than 2%. In the pediatric population, dumping syndrome is described in children who have undergone Nissen fundoplication.
Several treatments can be proposed to a patient with dumping. Initially a diet of several small meals with a low concentration of mono-and disaccharides is prescribed and the patient is asked to avoid liquids during a meal. Several medical treatments can be utilized as guar gum, to increase the viscosity and reduce gastric emptying; pectine, to avoid a late hypoglycemia; acarbose, to block the digestion of saccharides. Some of them have only a partial effect or important side effects.
Surgical interventions like an interposition of an antiperistaltic jejunal segment will reduce the intestinal motility or a Roux-en-Y construction can be created. These surgical interventions are sometimes necessary but remain quite invasive and not always useful.
Somatostatin analogues have been used with success in patients with dumping syndrome. They exert a strong inhibitory effect on the release of insulin and several gut-derived hormones. The effectiveness of analogues in controlling the symptoms of both early and late dumping has been demonstrated in several randomized control trials. Somatostatin analogues interfere with the pathophysiology of a dumping syndrome in several ways. Somatostatin analogues reduce the secretion of insulin and prevents the occurrence of a late hypoglycaemia; decrease the concentration of different hormones responsible for the vaso-dilatation and the activation of the renin-angiotensine system that is seen in the early faze of the dumping syndrome. Somatostatin has also an effect on gastric motility and transit time.
One of the main problems is the high cost and daily subcutaneous administration of somatostatin analogues .
Somatuline® Autogel is a slow-release formulation that requires only monthly injection and supply high-dose, stable serum levels of lanreotide. These agents provide improved patient compliance since they are administered on a monthly schedule.
The purpose of this study is to assess if Somatuline autogel 90 mg is effective in the treatment of dumping syndrome. This will be a 27 weeks double blinded placebo-controlled cross-over multicenter study assessing the effect of Somatuline 90 mg in patients with dumping syndrome.
Reports on the therapeutic effectiveness of lanreotide in the management of dumping symptoms are scarce and based on small numbers of patients. Data on the effect of lanreotide in the treatment of dumping are missing. In this trial, all patients will be treated with Somatuline ® Autogel 90 mg. From a pharmacokinetic point of view, all patients will have reached steady state concentration of lanreotide after 12 weeks of treatment. After 12 weeks, a wash-out period of 4 weeks is inserted before patients will be crossed over to placebo or active treatment at week 16.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lanreotide slow release 90 mg | Experimental | Drug: Lanreotide 90 mg slow release formulationPatients receive lanreatide slow release (Somatuline autogel) 90 mg every four weeks via a deep subcutaneous injection, three times. After a wash out period of 4 weeks they receive a similar placebo every for weeks, three times. |
| Placebo | Placebo comparator | Drug: PlaceboPatients receive a deep subcutanous injection of placebo every four weeks, three times. After a wash out of three weeks, they will receive somatuline 90 mh via a deep subcutanous injection every four weeks, three times. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with clinical suspect of a dumping syndrome with a total dumping score* (early and late symptoms) ≥ 10, and
- Age > 18 years
- Diet of 6 meals a day with low concentration of mono- and disaccharides during 1 month before inclusion without sufficient improvement (= evaluation by physician and patient)
Key exclusion criteria (8 listed)
- Patients who have been treated with Somatuline or Sandostatine LAR in the past
- Cholecystolithiasis
- Diabetes Mellitus
- Coeliakie and Giardia
- Untreated severe oesophagitis
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 90 mg slow release formulationAlso: Somatulin autogelLanreotide 90 mg slow release formulation is injected deep subcutaneously, every 4 weeks, three times and compared to placebo | Drug | Lanreotide slow release 90 mg |
| PlaceboPlacebo for somatuline slow release 90 mg | Drug | Placebo |
Primary outcome
Change from Baseline Total Dumping score after treatment with Somatuline 90 mg and after placebo.
Time frame: at week 11 and week 27 during the study
Early dumping starts immediately after a meal, within 1 hour (< 1 hour). Late dumping starts later than 1 hour after a meal (≥ 1 hour). Each item is scored from zero (not present) 1 (mild) , 2 (moderate) and 3 (severe). Early dumping symptoms : sweating, flushes, dizziness, palpitations, abdominal pain, diarrhea, bloating, nausea. Late dumping symptoms : sweating, palpitations, hunger, drowsiness to unconsciousness, shaking and aggression. The change in dumping score will be assessed after 11 weeks and a second time after cross over at week 27. Additionally, the overall improvement is assessed by asking "how do you feel compared with your situation before starting the study at week 11. The same question is asked at week 27. Additionally at week 27 the following question is asked " How do you feel compared with your situation 4 months ago ?" Scoring is done on a 7 point Likert scale.
2 secondary outcomes
Change in quality of life.
Time frame: week 0, 11, 16 and 27
The difference in number of participants with adverse events between somatuline 90 mg versus placebo
Time frame: at week 27 (end of the study)
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 27 Jan 2023.
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Continuous Glucose Monitoring With iCan i3 in Post-Bariatric Patients With Late Dumping Syndrome
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites 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 90 mg slow release formulation in people with Dumping Syndrome, run by Universitaire Ziekenhuizen KU Leuven at 3 sites 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 8 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 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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 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?
Change from Baseline Total Dumping score after treatment with Somatuline 90 mg and after placebo. (time frame: at week 11 and week 27 during the study). 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 27 Jan 2023.