Trial Search Results

A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04

A 52-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG) with respect to the core signs and symptoms of diabetic gastroparesis.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Allergan

Stanford Investigator(s):

Intervention(s):

  • Drug: Placebo
  • Drug: Relamorelin

Phase:

Phase 3

Eligibility


Inclusion Criteria:

Two different groups of participants may enter into the study:

   1. 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

   2. 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

Exclusion Criteria:

   1. 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)

   2. Rollover Participants

   •Participants will be excluded from this study if any of the lead-in study exclusion
   criteria apply at the Screening Visit and at the end of the Run-in Period for
   randomization into the Treatment Period of studies RLM-MD-01 and RLM-MD-02, except as
   specified in the inclusion criteria

   3. 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Alexandria George
650-723-6815
Recruiting