i

A 52-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis

PHRR181204-001993

RLM-MD-04

2018-CT0450

A 52-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis

multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the safety and efficacy of Relamorelin in Patients with Diabetic Gastroparesis

Regime Classification Priority
2017 - 2022 Research to enhance and extend healthy lives
Start Date Duration in Months Target Completion Date Actual Completion Date
2019-10-08 13 2020-11-08 2020-09-22

Terminated

Sponsor has decided to no longer pursue the clinical development of relamorelin for the treatment of diabetic gastroparesis. (End of Trial Notification DTN 20200928091832)

Institution Classification Region LTO #
Allergan Ltd. Private Business United States of America N/A
Institution Classification Region LTO #
PAREXEL Clinical Research (Philippines) Ltd. Corp. Private Business NCR CDRR-NCR-CRO-4
Institution Region
Allergan Ltd. United States of America
Name E-Mail Institution and Institution Address
Teddy Dizon Teddy.Dizon@allergan.com 21st Floor Robinsons Cyberscape Beta Topaz & Rudy Roads, Ortigas Center PASIG, Manila, 1605 Philippines
Name E-Mail Institution and Institution Address
Mary Hazel Lauron MaryHazel.Lauron@parexel.com 21st Floor Robinsons Cyberscape Beta Topaz & Rudy Roads, Ortigas Center PASIG, Manila, 1605 Philippines
Name Expertise Affiliation
Aretha Ann Liwag, MD Principal Investigator West Visayas State University
Cecilia A. Jimeno, MD Principal Investigator San Juan De Dios Educational Foundation, Inc.,
Ernesto Ang, MD Principal Investigator Cardinal Santos Medical Center
Marsha Tolentino, MD Principal Investigator Perpetual Succour Hospital
Michael Villa, MD Principal Investigator St. Luke's Medical Center - Quezon City
Roberto C. Mirasol, MD Principal Investigator Manila Doctors Hospital
Rosa Allyn G. Sy, MD Principal Investigator Ospital ng Makati
Project Location Institutional Ethics Review Board
West Visayas State University West Visayas State University Unified Biomedical Research Ethics Review Committee
San Juan De Dios Educational Foundation, Inc., N/A
Cardinal Santos Medical Center Cardinal Santos Medical Center Ethics Review Committee
Perpetual Succour Hospital Perpetual Succour Hospital Institutional Ethics and Review Board
St. Luke's Medical Center - Quezon City St. Luke's Medical Center Institutional Ethics Review Board
Manila Doctors Hospital Manila Doctors Hospital Institutional Review Board
Ospital ng Makati Ospital ng Makati Ethics Review Committee

Diabetic Gastroparesis

efficacy of relamorelin from placebo

Unspecified

Terminated

Clinical Trial

RLM-MD-04

20160629124508

2018-11-08

0000-00-00

35

1

Unspecified

2019-10-08

Inclusion CriteriaRollover   participantsParticipants who were not randomization-eligible at the end of the Run-in Period of lead-in Studies RLM-MD-01 or RLM-MD-02 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 DGSSD) except that:1.    They had zero vomiting episodes and an average daily DGSSS of ≥ 12 at the end of the lead-in study Run-in Period, as reported using the electronic hand-held device;OR2.    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 th electronic hand-held device.De Novo  participantsParticipants who undergo screening and run-in procedures for Study RLM-MD-04 are eligible to be included in the study if all of the following criteria apply:1.    Male or female participants aged 18 years or older at Screening (V isit –2)2.    T 1DM or T 2DM of at least 5 years’duration, with controlled and stable blood glucose levels (ie, no episodes of diabetic ketoacidosis, Hyperosmolar Hyperglycemic Nonketotic Diabetic Syndrome, or severe hypoglycemia within the 6 months preceding Screening [V isit –2])3.    HbA 1c ≤ 11.0% at Screening (V isit –2) in participants being treated with oral and/or parenteral medications for T 1DM or T 2DM with the goal of achieving controlled and stable glucose levels4.    DG defined as at least a 3-month history prior to Screening (V isit –2) of symptoms (one of which must be nausea) on an ongoing basis that are suggestive of GP (eg, nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety) 5.    Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and Follow-up PeriodA female participant is eligible to participate if she is not pregnant (has a negative urine pregnancy result prior to randomization; see A ppendix 5), not breastfeeding, and at least one of the following conditions applies:a.    Not a woman of childbearing potential (WOCBP) ORb.    A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 7 days after the last dose of study treatment6.    Documentation of absence of an obstructing lesion on upper endoscopy or other equivalent diagnostic test, performed at some time before Screening (Visit –2) but after the appearance of symptoms that led to the diagnosis of Diabetic Gastroparesis7.    Nausea and/or at most a single episode of vomiting during the 2 weeks prior to Screening (Visit –2), as ascertained by participant history8.    Delayed GE confirmed by abnormal GEBT, defined as GE half-time (t½) ≥ 79 minutes at the start of the placebo-controlled Run-in Period (V isit 2 of RLM-MD-01, RLM-MD-02, or this study). In countries where the GEBT is not available, delayed GE may be confirmed by abnormal scintigraphy result (> 60% retention at 2 hours or > 10% at 4 hours). Refer to the Study Reference Manual9.  BMI > 18.5 kg/m210.    Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study proceduresadditional inclusion criteria for randomization after the 2-week, placebo Run-in Period:11.    Compliance with the entry of data into the hand-held electronic device on at least 10 of 14 days during the Run-in Period.12.    Compliance with administration of SC twice daily injections, as evidenced by entries made by the participant using the electronic, hand-held device on at least 10 of 14 days during the Run-in Period.13.    The average of the daily DGSSS from the 2-week, Run-in Period must be ≥ 12Exclusion CriteriaRollover    participantsParticipants will be excluded from this study if any of the lead-in study exclusion criteria apply at Screening (V isit 1) and at the end of the Run-in Period (Visit 3) for randomization into theTreatment Period of Studies RLM-MD-01 and RLM-MD-02, except as specified in the inclusion criteria De Novo Participants1.    Symptomatic Irritable Bowel Syndrome at Screening (Visit –2)2.    Small intestinal bacterial overgrowth (SIBO) at Screening (Visit –2)3.    History of anorexia nervosa, binge-eating, bulimia, or other eating disorder within 5 years of Screening (V isit –2)4.    History of intestinal malabsorption (including celiac disease even if well-controlled on a gluten-free diet) or pancreatic exocrine insufficiency; also, history of non-celiac gluten sensitivity5.    History of belching disorders, other nausea and vomiting disorders (eg, chronic nausea and vomiting syndrome, cyclic vomiting syndrome, cannabinoid hyperemesis syndrome), or rumination syndrome6.    History of chronic obstructive pulmonary disease or other causes of pulmonary dysfunction that have resulted in CO2 retention7.    Gastric or duodenal ulcer within 3 months of Screening (V isit 1)8.    Evidence of hepatic disease defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 x ULN, and/or direct bilirubin ≥ 2 x ULN at Screening (V isit -2)9.    History of malignancy in the 3 years prior to V isit 1, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer10.    Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube for feeding or decompression11.    Use of metoclopramide, domperidone, prucalopride, macrolide antibiotics (eg, erythromycin, clarithromycin, azithromycin), or other drugs considered to be GI pro- motility agents (T able 7-2) for at least 10 days prior to the start of the Run-in Period (V isit –1)12.    Positive results on the urine drug screen will exclude participants from participating in the study. T he significance of a positive screen result for drugs prescribed for the participant (eg, barbiturates, benzodiazepines, amphetamines, but not cannabinoids) should be assessed by the Investigator as to whether their stable-dose usage is clinically appropriate, and, therefore, should not be exclusionary; use of these drugs on an as-needed basis is not allowed13.    Currently taking opiates, or expecting to use opiates during the course of the clinical study. 14.    Treatment with glucagon-like peptide-1 (GLP-1) agonist for at least 6 weeks prior to the start of the Run-in Period (Visit –1)15.    History of pyloric injection of botulinum toxin within 6 months of screening16.    History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, or bariatric procedure (a history of diagnostic endoscopy is not exclusionary)17.    Randomization in any previous study in which relamorelin was a treatment18.    Estimated glomerular filtration rate (eGFR) of

Interventional

Relamorelin

Relamorelin 10 μg or placebo, twice daily, SC.

Date Amendment Classification Reason
2019-01-29 Amendments related to the trial arrangements Change of the trial site or addition of new site
2019-02-01 Amendments related to the protocol Informed consent
2019-05-02 Amendments related to the protocol Patient Recruitment Materials

Randomized

Double Blind

Unspecified

Parallel

•    To compare the efficacy of relamorelin with that of placebo in participants with Diabetic Gastroparesis with respect to Diabetic Gastroparesis Symptom Severity Score and V omiting Frequency•    To compare the safety of relamorelin with that of placebo in participants with Diabetic Gastroparesis

Phase III

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others
©2021 HERDIN PLUS. All rights reserved. | Contact Us | Keep up to date