Submitted by: Margarett Lerin 2018-11-30 00:00:00 Last Updated by: Margarett Lerin 2019-05-10 09:32:28 Export to PDF

A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis

PHRR181204-001990

RLM-MD-01

2018-CT0448

A 12-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 evaluate 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
2019-02-28 7 2019-09-28 0000-00-00

Pending

Clinical Trial not yet started

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 Amount Region
Allergan Ltd. N/A United States of America
Name E-Mail Phone Number Postal Address
Teddy Dizon TeddyDizon@allergan.com +63 (2) 910-4415 21st Floor Robinsons Cyberscape Beta Topaz and Ruby road Ortigas Philippines
Name E-Mail Phone Number Postal Address
Marie Hazel K. Lauron maryhazel.lauron@allergan.com +63 (2) 910-4415 21st Floor Robinsons Cyberscape Beta Topaz and Ruby road Ortigas Philippines
Name Expertise Affiliation
Ernesto Ang, MD Endocrinology Cardinal Santos Medical Center
Cecilia A. Jimeno, MD Endocrinology San Juan De Dios Educational Foundation, Inc.,
Michael Lim Villa, MD Endocrinology St. Luke's Medical Center - Quezon City
Aretha Ann Liwag, MD Endocrinology West Visayas State University
Roberto C. Mirasol, MD Endocrinology Manila Doctors Hospital
Marsha Tolentino, MD Endocrinology Perpetual Succour Hospital
Rosa Allyn G. Sy, MD Endocrinology Ospital ng Makati
Project Location Institutional Ethics Review Board
Cardinal Santos Medical Center Cardinal Santos Medical Center Ethics Review Committee
San Juan De Dios Educational Foundation, Inc., N/A
St. Luke's Medical Center - Quezon City St. Luke's Medical Center Institutional Ethics Review Committee
West Visayas State University West Visayas State University Unified Biomedical Research Ethics Review Committee
Manila Doctors Hospital Manila Doctors Hospital Institutional Review Board
Perpetual Succour Hospital Perpetual Succour Hospital Institutional Ethics and Review Board
Ospital ng Makati Ospital ng Makati Ethics Review Committee

Diabetic Gastroparesis

efficacy of relamorelin to placebo

Unspecified

Pending

Clinical Trial

20180629124215

2018-11-08

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 Others

Inclusion CriteriaParticipants are eligible to be included in the study only if all of the following criteria apply:1.    Male and female participants aged 18 years or older at screening (Visit 1)2.    T1DM 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 [Visit 1])3.    HbA 1c ≤11.0% at screening (Visit 1) in participants being treated with oral and/or parenteral medications for T1DM or T2DM with the goal of achieving controlled and stable glucose levels4.    DG defined as at least a 3-month history prior to screening (Visit 1) of symptoms on an ongoing basis that are suggestive of GP (eg, nausea, abdominal pain, post-prandial 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 Appendix 5), not breastfeeding, and at least one of the following conditions applies:a.    Not a woman of childbearing potential (WOCBP) as defined in A ppendix 5 ORb.    A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 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 1) but after the appearance of symptoms that led to the diagnosis of Diabetic Gastroparesis (DG)7.    At least 2 vomiting episodes during the 2 weeks prior to screening (Visit 1), 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 (Visit 2). 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). 9.  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 procedures11.    Compliance with the entry of data into the hand-held electronic device on at least 10 of 14 days during the placebo Run-in Period12.    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 placebo Run-in Period13.    At least one vomiting episode at any time during the placebo Run-in Period, as recorded in the Diabetic Gastroparesis Symptom Severity Diary (DGSSD), using the electronic hand-held device14.    The average of the daily Diabetic Gastroparesis Symptom Severity Score (DGSSS) from the 2-week, placebo Run-in Period must be ≥ 16Exclusion CriteriaParticipants are excluded from the study if any of the following criteria apply:1.    Symptomatic Irritable Bowel Syndrome at Screening (Visit 1)2.    Small intestinal bacterial overgrowth (SIBO) at Screening (Visit 1)3.    History of anorexia nervosa, binge-eating, bulimia, or other eating disorder within 5 years of screening (Visit 1)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 (Visit 1)8.    Evidence of hepatic disease defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 x ULN, and/or direct bilirubin ≥ 2 x ULN9.    History of malignancy in the 3 years prior to Visit 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 (Table 7-2) for at least 10 days prior to the start of the Run-in Period (Visit 2)12.    Positive results on the urine drug screen at Screening (Visit 1) . T he significance of a positive screen result for drugs prescribed for the participant (e.g., 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 opioids, or expecting to use opioids during the course of the clinical study. (see Section 7.7.1 for an exception to this prohibition)14.    Treatment with glucagon-like peptide-1(GL P-1) agonist for at least 6 weeks prior to the start of the Run-in Period (Visit 2)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

Unspecified

Relamorelin 10 μg or placebo, twice daily, SC

Randomized

Double Blind

Unspecified

Parallel

•To compare the efficacy of relamorelin with placebo in participants with DG with respect to a composite of the following core signs and symptoms of DG:  (Nausea, Abdominal pain, Postprandial fullness, Bloating)•To compare the efficacy of relamorelin with placebo in participants with DG with respect to vomiting frequency

Phase III

35

Unspecified

Unspecified

28 Feb 2019

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others

Copyright © One Window Project 2018. All rights reserved.