SOMATULINE Autogel 90 mg IN DUMPING SYNDROME
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|ClinicalTrials.gov Identifier: NCT01923649|
Recruitment Status : Unknown
Verified January 2013 by Universitaire Ziekenhuizen Leuven.
Recruitment status was: Recruiting
First Posted : August 15, 2013
Last Update Posted : August 22, 2013
|Condition or disease||Intervention/treatment||Phase|
|Dumping Syndrome||Drug: Lanreotide 90 mg slow release formulation Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||SOMATULINE Autogel 90 mg IN DUMPING SYNDROME|
|Study Start Date :||April 2008|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
Experimental: Lanreotide slow release 90 mg
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.
Drug: Lanreotide 90 mg slow release formulation
Lanreotide 90 mg slow release formulation is injected deep subcutaneously, every 4 weeks, three times and compared to placebo
Other Name: Somatulin autogel
Placebo Comparator: Placebo
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.
Placebo for somatuline slow release 90 mg
- 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.
- Change in quality of life. [ Time Frame: week 0, 11, 16 and 27 ]To assess the effect of Somatuline 90 mg versus placebo on a standardized quality of life questionnaire (QOL SF-36).
- The difference in number of participants with adverse events between somatuline 90 mg versus placebo [ Time Frame: at week 27 (end of the study) ]To assess the tolerability of Somatuline 90 mg versus placebo.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923649
|Contact: Raf Bisschops, MD, PhDfirstname.lastname@example.org|
|Contact: Jan Tack, MD, PhDemail@example.com|
|AZ St. Lucas||Completed|
|Brugges, Belgium, 8310|
|Genk, Belgium, 3600|
|University Hospitals Leuven||Recruiting|
|Leuven, Belgium, 3000|
|Contact: Raf Bisschops, MD, PhD +3216344225 firstname.lastname@example.org|
|Contact: Jan Tack, MD PhD +3216344225 email@example.com|
|Principal Investigator: Raf Bisschops, MD PhD|
|Sub-Investigator: Jan Tack, MD PhD|