SOMATULINE Autogel 90 mg IN DUMPING SYNDROME

NCT01923649 | Completed Phase 2

• 2 other identifiers: S509662008-000643-34
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Dumping Syndrome

Keywords

postoperative dumping; somatostatin analogues; somatulin; lanreotide; dumping syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  at week 11 and week 27 during the study

Secondary Outcomes (2)

• Change in quality of life.

  week 0, 11, 16 and 27

• The difference in number of participants with adverse events between somatuline 90 mg versus placebo

  at week 27 (end of the study)

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Lanreotide 90 mg slow release formulation DRUG

Lanreotide 90 mg slow release formulation is injected deep subcutaneously, every 4 weeks, three times and compared to placebo

Also known as: Somatulin autogel

Lanreotide slow release 90 mg

Placebo DRUG

Placebo for somatuline slow release 90 mg

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Ipsen: collaborator

Study Sites (3)

AZ St. Lucas

Brugges, 8310, Belgium

Location

ZOL Genk

Genk, 3600, Belgium

Location

University Hospitals Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Dumping Syndrome

Interventions

lanreotide; Delayed-Action Preparations

Condition Hierarchy (Ancestors)

Postgastrectomy Syndromes; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Drug Delivery Systems; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2013
• First Posted: August 15, 2013
• Study Start: April 1, 2008
• Primary Completion: December 2, 2013
• Study Completion: December 2, 2013
• Last Updated: January 27, 2023

Record last verified: 2017-07

Locations

BE (3)