E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Weight regain post bariatric surgery |
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E.1.1.1 | Medical condition in easily understood language |
Weight regain after stomach altering weight loss surgery because of being overweight |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to study the effect of naltrexone/bupropion in combination with the BOT module on successful weight loss(>5% weight loss) after 22 weeks in patients with weight regain after bariatric surgery, compared to the regular BOT module. |
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E.2.2 | Secondary objectives of the trial |
These are the secondary objectives: a) To describe the persistence of therapy of Mysimba after bariatric surgery b) To describe the maximal tolerated dosage c) To study adverse effects of the use of Mysimba d) To monitor and compare weight loss more long term (up to 12 months) after the start of Mysimba in both study groups e) To evaluate eating behaviour in patients with weight regain after bariatric surgery who used Mysimba compared to patients on the regular module according to the BODY-Q questionnaire
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
To be eligible to participate in this study, a subject must meet all of the following criteria: • 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
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E.4 | Principal exclusion criteria |
A potential subject who meets any of the following criteria will be excluded from participation in this study: • Anatomical or surgical abnormalities for which revisional surgery is indicated. • Use of the following medication Monoamino-oxidase inbibitors (MAO), selective serotonin reuptake inhibitor (SSRI), Tricyclic antidepressants (TCA), haloperidol, risperidone, opioids, antiarrhythmics, betablockers, antiviral medication (HIV) • Pregnancy or breastfeeding • 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 • Patients withdrawing from alcohol or benzodiazepines • Patients who are not able to understand the informed consent form and patient information.
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E.5 End points |
E.5.1 | Primary end point(s) |
Our primairy endpoint is to reach succesfull weight loss defined as >5% weight loss after 22 weeks of administering the investigational drug, Mysimba. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
22 weeks after start of the study |
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E.5.2 | Secondary end point(s) |
Our secondary endpoints are: - persistence of the entire therapy - tolerating the full dosage - percentage of patients experiencing adverse effects - sustained weight loss untill 12 months after the study start - percentage of patients with a lowerd BODY-Q questionaire score in the investigational group compared to the regular group |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
For all secondary endpoints we will evaluate at 22 weeks after start of study, except for the long term weight loss endpoint. This will be monitored up to 12 months after the study start. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Regular group who follow the same Back on Track Module |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trail will be the last visit of the last subject undergoing the trail. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |