Postoperative Dumping SyndromePhase 2CSOM230BBE01TNCT01895296
Study to Assess Safety and Efficacy of sc Pasireotide in Patients With Dumping Syndrome
A Phase 2 study testing Pasireotide in people with Postoperative Dumping Syndrome, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Dumping Syndrome consists of (1) a too rapid gastric emptying, (2) an inappropriate release of GI hormones (as a reaction to the hyperosmolar contents in the duodenum) and (3) an hyperinsulinemic response to a too rapid absorption of glucose. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Dumping Syndrome
- What is being tested?
- Pasireotide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2008to Jan 2010
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged between 18 and 80 years.
- Patients with diagnosis of Dumping Syndrome:
- Having symptoms of Dumping Syndrome (sum of combined Dumping Syndrome score ≥10) AND
- either (a) having had a documented episode of postprandial hypoglycemia in the medical history
- or either (b) demonstrating a hypoglycemia (<60mg/dl) or hematocrite increase of > 3% or a pulse increase of 10 bpm after an oral glucose tolerance test with 75 g of glucose.
- Patients for whom written informed consent to participate in the study has been obtained. Patients will need to provide their informed consent prior to starting any medication washout period
Who cannot join
- Patients who have undergone major surgery/surgical therapy for any cause within 1 month
- Patients with symptomatic cholecystolithiasis in the medical history unless a cholecystectomy is performed (ultrasound abdomen maximum 6 months old).
- Patients who have failed treatment with somatostatin analogues in the past (specifically patients who have been treated with octreotide s.c. for more than 2 days or with a long acting somatostatin analogue for more than 8 weeks).
- Patients who have been treated with somatostatin analogues during the last 12 weeks before inclusion.
- Patients who have a known hypersensitivity to somatostatin analogues.
- Patients with the diagnosis of Diabetes Mellitus
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- Patients with important co-morbidity (cardiac, pulmonary, renal , hepatic diseases)
- Patients with abnormal coagulation (PT and PTT elevated by 30% above normal limits)
- Patients receiving anticoagulants that affect PT or PTT
- Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control. Female patients must use barrier contraception in addition to condoms. If oral contraception is used, the patient must have been practicing this method for at least three months prior to the enrollment and must agree to continue the oral contraceptive throughout the course of the study, and for three months after the study has ended. Male patients who are sexually active are required to use condoms during the study and for 3 months afterwards.
- History of immunocompromise, including a positive HIV test result (ELISA and Western blot). A HIV test will not be required; however, previous medical history will be reviewed
- Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
- Patients with additional active malignant disease within the last five years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix)
- Patients with the presence of active or suspected acute or chronic uncontrolled infection
- Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Randomized, Placebo-controlled Study to Assess Safety and Efficacy of sc Pasireotide in Patients With Dumping Syndrome
Dumping Syndrome consists of (1) a too rapid gastric emptying, (2) an inappropriate release of GI hormones (as a reaction to the hyperosmolar contents in the duodenum) and (3) an hyperinsulinemic response to a too rapid absorption of glucose. Because it is not well known which somatostatin receptor(s) (sst1-5) influence(s) Dumping Syndrome most, the goal of this trial is to evaluate :
- the effect of pasireotide (sst1, 2, 3, 5 agonist) on the control of gastric emptying.
- the effect of pasireotide (sst1, 2, 3, 5 agonist) on the release of GI hormones (during OGTT).
- the effect of pasireotide (sst1, 2, 3, 5 agonist) on the hyperinsulimic response (during OGTT).
- the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of objective parameters of Dumping Syndrome (hematocrit (Hct), pulse rate and occurrence of hypoglycemia after an Oral Glucose Tolerance Test (OGTT) with 75g of glucose)
- the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of overall symptoms as measured by the combined Dumping Syndrome score
- the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of symptoms as measured by (a) early and (b) late phase dumping symptom score separately
- the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of quality of life (QoL SF-36)
Read the detailed description
This will be a single centre, randomized, double-blind, controlled cross-over study during 35 days.
After a 4 weeks screening period, patients who fulfill the entrance criteria will be randomly assigned on a 1:1 basis to either the pasireotide treatment arm or to the placebo treatment arm. They will be treated with pasireotide sc or placebo sc for 2 weeks. After 2 weeks, patients will be switched to the other treatment arm after a 7 days wash out period. This phase is double-blind: both the patient and investigator will be blinded to treatment assignment.
- Conditions
- Postoperative Dumping Syndrome
- Being tested
- Pasireotide, Placebo
- Keywords
- dumping syndrome, OGTT, hypoglycemia
- Medical subject headings
- Dumping Syndrome, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PasireotideDrug
Also called SOM230
somatostatin analogue pasireotide
PlaceboDrug
placebo s.c.
| Study group | Role | What they receive |
|---|---|---|
| Pasireotide | Experimental | pasireotide 300 microgram s.c. t.i.d. Receives: Drug: Pasireotide |
| Placebo | Placebo comparator | saline s.c. t.i.d. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy endpoint: symptoms related to Dumping Syndrome Severity Score
The dumping score is the sum of the early and late dumping symptoms. Early dumping starts immediately after a meal, within 1 hour (< 1 hour). Late dumping starts later than 1 hour after a meal (≥ 1 hour). In case a symptom starts immediately after a meal and lasts longer than 1 hour, the score for early AND late dumping should be ticked.
Dumping Score None Mild Moderate Severe Early Dumping 0 1 2 3 Sweating 0 1 2 3 Flushes 0 1 2 3 Dizziness 0 1 2 3 Palpitations 0 1 2 3 Abdominal pain 0 1 2 3 Diarrhea 0 1 2 3 Bloating 0 1 2 3 Nausea 0 1 2 3
None Mild Moderate Severe Late Dumping 0 1 2 3 Sweating 0 1 2 3 Palpitations 0 1 2 3 Hunger 0 1 2 3 Drowsiness to unconsciousness 0 1 2 3 Trembling 0 1 2 3 Irritability 0 1 2 3
Measured: 2 weeks
Secondary outcomes (1)
Effect on hypoglycemia
- The secondary efficacy variables include the proportion of patients with reduced hypoglycemic events
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startSep 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Dr Jan Tack, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Jan Tack, M.D., Ph.D., Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895296
- Sponsor's protocol ID
- CSOM230BBE01T
- Other IDs
- 2008-000700-84, 2008
- Acronym
- CSOM230BBE01T
- Status last verified
- Jul 2013
- First submitted
- 1 Jul 2013
- Last updated
- 10 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Randomized, Placebo-controlled Study to Assess Safety and Efficacy of sc Pasireotide in Patients With Dumping Syndrome
- ClinicalTrials.gov ID
- NCT01895296
- Acronym / sponsor ID
- CSOM230BBE01T / CSOM230BBE01T
- Conditions
- Postoperative Dumping Syndrome
- Keywords
- dumping syndrome, OGTT, hypoglycemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 10 Jul 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.
Dumping Syndrome consists of (1) a too rapid gastric emptying, (2) an inappropriate release of GI hormones (as a reaction to the hyperosmolar contents in the duodenum) and (3) an hyperinsulinemic response to a too rapid absorption of glucose. Because it is not well known which somatostatin receptor(s) (sst1-5) influence(s) Dumping Syndrome most, the goal of this trial is to evaluate :
- the effect of pasireotide (sst1, 2, 3, 5 agonist) on the control of gastric emptying.
- the effect of pasireotide (sst1, 2, 3, 5 agonist) on the release of GI hormones (during OGTT).
- the effect of pasireotide (sst1, 2, 3, 5 agonist) on the hyperinsulimic response (during OGTT).
- the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of objective parameters of Dumping Syndrome (hematocrit (Hct), pulse rate and occurrence of hypoglycemia after an Oral Glucose Tolerance Test (OGTT) with 75g of glucose)
- the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of overall symptoms as measured by the combined Dumping Syndrome score
- the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of symptoms as measured by (a) early and (b) late phase dumping symptom score separately
- the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of quality of life (QoL SF-36)
Detailed description
This will be a single centre, randomized, double-blind, controlled cross-over study during 35 days.
After a 4 weeks screening period, patients who fulfill the entrance criteria will be randomly assigned on a 1:1 basis to either the pasireotide treatment arm or to the placebo treatment arm. They will be treated with pasireotide sc or placebo sc for 2 weeks. After 2 weeks, patients will be switched to the other treatment arm after a 7 days wash out period. This phase is double-blind: both the patient and investigator will be blinded to treatment assignment.
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 |
|---|---|---|
| Pasireotide | Experimental | Drug: Pasireotidepasireotide 300 microgram s.c. t.i.d. |
| Placebo | Placebo comparator | Drug: Placebosaline s.c. t.i.d. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients aged between 18 and 80 years.
- Patients with diagnosis of Dumping Syndrome:
- Having symptoms of Dumping Syndrome (sum of combined Dumping Syndrome score ≥10) AND
- Patients for whom written informed consent to participate in the study has been obtained. Patients will need to provide their informed consent prior to starting any medication washout period
Key exclusion criteria (15 listed)
- Patients who have undergone major surgery/surgical therapy for any cause within 1 month
- Patients with symptomatic cholecystolithiasis in the medical history unless a cholecystectomy is performed (ultrasound abdomen maximum 6 months old).
- Patients who have failed treatment with somatostatin analogues in the past (specifically patients who have been treated with octreotide s.c. for more than 2 days or with a long acting somatostatin analogue for more than 8 weeks).
- Patients who have been treated with somatostatin analogues during the last 12 weeks before inclusion.
- Patients who have a known hypersensitivity to somatostatin analogues.
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 |
|---|---|---|
| PasireotideAlso: SOM230somatostatin analogue pasireotide | Drug | Pasireotide |
| Placeboplacebo s.c. | Drug | Placebo |
Primary outcome
Primary efficacy endpoint: symptoms related to Dumping Syndrome Severity Score
Time frame: 2 weeks
The dumping score is the sum of the early and late dumping symptoms. Early dumping starts immediately after a meal, within 1 hour (< 1 hour). Late dumping starts later than 1 hour after a meal (≥ 1 hour). In case a symptom starts immediately after a meal and lasts longer than 1 hour, the score for early AND late dumping should be ticked. Dumping Score None Mild Moderate Severe Early Dumping 0 1 2 3 Sweating 0 1 2 3 Flushes 0 1 2 3 Dizziness 0 1 2 3 Palpitations 0 1 2 3 Abdominal pain 0 1 2 3 Diarrhea 0 1 2 3 Bloating 0 1 2 3 Nausea 0 1 2 3 None Mild Moderate Severe Late Dumping 0 1 2 3 Sweating 0 1 2 3 Palpitations 0 1 2 3 Hunger 0 1 2 3 Drowsiness to unconsciousness 0 1 2 3 Trembling 0 1 2 3 Irritability 0 1 2 3
1 secondary outcome
Effect on hypoglycemia
Time frame: 2 weeks
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 10 Jul 2013.
Related trials for Postoperative Dumping Syndrome
Active, not recruiting
Feasibility Study of Middle Segmental Gastrectomy (MSG) for Gastric Cancer.
Gastric Cancer, Gastric Adenocarcinoma
RecruitingObservational study
Dumping Syndrome After Esophagectomy
Esophagectomy, Dumping Syndrome
Recruiting
Continuous Glucose Monitoring With iCan i3 in Post-Bariatric Patients With Late Dumping Syndrome
Dumping Syndrome, Post-bariatric Hypoglycemia
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Dumping Syndrome and Esophageal Atresia
Oesophageal Atresia, Dumping Syndrome
Active, not recruiting
Comparing Dumping Symptoms and Quality of Life 6 Months After Sleeve Gastrectomy With or Without Transit Bipartition in Adults With Obesity
Obesity, Morbid Obesity
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 Tack, M.D., Ph.D. principal investigator
Universitaire Ziekenhuizen KU Leuven
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 Pasireotide in people with Postoperative Dumping Syndrome, run by Universitaire Ziekenhuizen KU Leuven 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 6 inclusion and 15 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 10 Jul 2013. 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. 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?
Primary efficacy endpoint: symptoms related to Dumping Syndrome Severity Score (time frame: 2 weeks). 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 10 Jul 2013.