Estudio de 52 semanas para comparar la eficacia de relamorelin con la del placebo en participantes con gastroparesia diabética (GD) en relación con los signos y síntomas centrales de la gastroparesia diabética.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Two different groups of participants may enter into the study:
Rollover Participants
Participants who were not randomization-eligible at the end of the Run-in Period of lead-in studies RLM-MD-01 (NCT03285308) or RLM-MD-02 (NCT03426345) are eligible to be randomized in the study if all of the following criteria apply:
•In the lead-in studies, participants must have met all screening visit and Run-in Period criteria for randomization into the Treatment Period (including compliance with dosing, entry of diary data into the Diabetic Gastroparesis Symptom Severity Diary (DGSSD)) except that:
They had zero vomiting episodes and an average daily Diabetic Gastroparesis Symptom Severity Score (DGSSS) of ≥12 at the end of the lead-in study Run-in Period, as reported using the electronic hand-held device; OR
They had vomiting episodes and an average daily DGSSS of ≥12 but \<16 at the end of the lead-in study Run-in Period, as reported using the electronic hand-held device
De Novo Participants
Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) of at least 5 years' duration, with controlled and stable blood glucose levels and hemoglobin A1c (HBA1c) ≤11%
DG defined as at least a 3-month history prior to Screening of symptoms (one of which must be nausea) on an ongoing basis that are suggestive of gastroparesis (GP) (e.g., nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety)
Compliance with the entry of data into the hand-held electronic device during the Run-in Period
Compliance with administration of subcutaneous (SC) twice daily injections during the Run-in Period
The average of the daily DGSSS from the 2-week, Run-in Period must be ≥12
De Novo Participants
History of anorexia nervosa, binge-eating, bulimia, or other eating disorder within 5 years of the Screening Visit
History of intestinal malabsorption or pancreatic exocrine insufficiency
History of belching disorders, other nausea and vomiting disorders
Gastric or duodenal ulcer within 3 months of Screening
History of malignancy in the 3 years prior to Screening, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube for feeding or decompression
Use of metoclopramide, domperidone, prucalopride, macrolide antibiotics (e.g., erythromycin, clarithromycin, azithromycin), or other drugs considered to be GI promotility agents for at least 10 days prior to the start of the Run-in Period
Currently taking opiates, or expecting to use opiates during the course of the clinical study
Treatment with glucagon-like peptide-1 (GLP-1) agonist for at least 6 weeks prior to the start of the Run-in Period
History of pyloric injection of botulinum toxin within 6 months of screening
History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, or bariatric procedure (a history of diagnostic endoscopy is not exclusionary)
Randomization in any previous study in which relamorelin was a treatment
Allergic to, or intolerant of egg, wheat, milk, or algae, as these are components of the gastric emptying breath test (GEBT) study meal

Criterios de exclusión

Both Rollover and De Novo Participants
•Participants with a known allergy or hypersensitivity to the study treatments and their excipients (i.e., mannitol or phenol)
Rollover Participants

Ubicaciones

Consultorios Asociados de Endocrinologia e InvestigaciÃ³n Cl

Buenos Aires, Buenos Aires, Argentina

Hospital Sirio Libanes

CABA, Buenos Aires, Argentina

Centro de Investigaciones Medicas Mar del Plata SRL

Mar del Plata, Buenos Aires, Argentina

CIPREC

Buenos Aires, Ciudad Autonoma deBuenos Aires, Argentina

Instituto de Investigaciones Clinicas de Rosario

Rosario, Santa Fe Province, Argentina

Instituto Medico Catamarca-I.ME.C

Rosario, Santa Fe Province, Argentina

Clinica Mayo de Urgencias Medicas Cruz Blanca SRL

San Miguel de Tucumán, Tucumán Province, Argentina

Centro Universitario de Investigacion en Farmacologia Clinic

Corrientes, Argentina

Instituto Privado de Investigaciones Clinicas de Cordoba

Córdoba, Argentina

CIDIM - Centro Integral de Diagnóstico por Imágenes Marchegian