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NCT04902625Not yet recruitingPhase 4

Applying Mysimba in patients with weight regain after bariatric surgery

Source: EU CTIS (euclinicaltrials.eu) · Last updated 17 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Dose response of Mysimba after Roux-and-Y gastric bypass or Gastric Sleeve surgery

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
157 (estimated)
First submitted
18 Dec 2024
Start date
2 Apr 2023
Lead sponsor
Zuyderland Medisch Centrum Stichting
Diseases
Obesity
NCT number
NCT04902625
EU CT number
2024-516645-39-01
EudraCT number
2021-002145-15

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 157
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Anatomical or surgical abnormalities for which revisional surgery is indicated.
  • Patients with excessive use of alcohol or drugs

Other illness

  • Use of the following medication Monoamino-oxidase inhibitors (MAO), selective serotonin reuptake inhibitor (SSRI), Tricyclic antidepressants (TCA), haloperidol, risperidone, opioids, antiarrhythmics, betablockers, antiviral medication (HIV)
  • Patients suffering from: o unregulated hypertension o a tumour in the central nervous system o severe liver failure o end stage kidney failure
  • Patients suffering from or with a history of insults
  • Patients with a history of: o bipolar disease o bulimia or anorexia nervosa

Other

  • Pregnancy or breastfeeding
  • Patients withdrawing from alcohol or benzodiazepines
  • Patients who are not able to understand the informed consent form and patient information.

Who the study is looking for

  • Patient is ≥18 and <75 years old
  • BMI before surgery was ≥ 35.0 kg/m2
  • Patient has undergone a primary banded/non-banded Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG)
  • Gaining more than 5% weight after reaching plateau phase of lowest weight To be eligible to participate in the control patient cohort for measuring bupropion and hydroxybupropion serum levels a subject must meet all of the following criteria: • Patient is ≥18 and <75 years old • Patient is obese (BMI > 30 kg/m2) • Patient on successful Mysimba steady maintenance dose

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Zuyderland Medisch Centrum Stichting
Coordinator of this site? Confirm its status
HeerlenNetherlandsNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.