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Trial record 4 of 7 for:    "Postgastrectomy Syndrome" | "Hormones, Hormone Substitutes, and Hormone Antagonists"

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
Sponsor:
Collaborator:
Ipsen
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:
The purpose of this study is to assess if Somatuline autogel 90 mg is effective in the treatment of dumping syndrome.

Condition or disease Intervention/treatment Phase
Dumping Syndrome Drug: Lanreotide 90 mg slow release formulation Drug: Placebo Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Placebo
Placebo for somatuline slow release 90 mg




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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).

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with clinical suspect of a dumping syndrome with a total dumping score* (early and late symptoms) ≥ 10, and

    1. 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
    2. documented spontaneous hypoglycemia (at least 1)
  2. Age > 18 years
  3. 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)

Exclusion Criteria:

  1. Patients who have been treated with Somatuline or Sandostatine LAR in the past
  2. Cholecystolithiasis
  3. Diabetes Mellitus
  4. Coeliakie and Giardia
  5. Untreated severe oesophagitis
  6. Untreated gastric and duodenum ulcer
  7. 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).
  8. Hypersensitivity to lanreotide or one of the compounds of the drug.

Information from the National Library of Medicine

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


Contacts
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Contact: Raf Bisschops, MD, PhD +32344225 raf.bisschops@uzleuven.be
Contact: Jan Tack, MD, PhD +32344225 jan.tack@uzleuven.be

Locations
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Belgium
AZ St. Lucas Completed
Brugges, Belgium, 8310
ZOL Genk Completed
Genk, Belgium, 3600
University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Contact: Raf Bisschops, MD, PhD    +3216344225    raf.bisschops@uzleuven.be   
Contact: Jan Tack, MD PhD    +3216344225    jan.tack@uzleuven.be   
Principal Investigator: Raf Bisschops, MD PhD         
Sub-Investigator: Jan Tack, MD PhD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Ipsen

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01923649     History of Changes
Other Study ID Numbers: S50966
2008-000643-34 ( EudraCT Number )
First Posted: August 15, 2013    Key Record Dates
Last Update Posted: August 22, 2013
Last Verified: January 2013
Keywords provided by Universitaire Ziekenhuizen Leuven:
postoperative dumping
somatostatin analogues
somatulin
lanreotide
dumping syndrome
Additional relevant MeSH terms:
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Postgastrectomy Syndromes
Hormones, Hormone Substitutes, and Hormone Antagonists
Dumping Syndrome
Syndrome
Disease
Pathologic Processes
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Lanreotide
Angiopeptin
Somatostatin
Antineoplastic Agents
Hormones
Physiological Effects of Drugs