A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis - Diabetic Gastroparesis Study 1

Allergan Ltd.0 sites2,500 target enrollmentSeptember 18, 2018

ConditionsDiabetic Gastroparesis MedDRA version: 20.1Level: PTClassification code 10051153Term: Diabetic gastroparesisSystem Organ Class: 10017947 - Gastrointestinal disorders Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Diabetic Gastroparesis
Sponsor: Allergan Ltd.
Enrollment: 2500
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 18, 2018

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Allergan Ltd.

Eligibility Criteria

Inclusion Criteria

•1\. Male and female participants aged 18 years or older at screening (Visit 1\)
•2\. T1DM or T2DM 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\. HbA1c \=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 levels
•4\. 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 period
•A female participant is eligible to participate if she is not pregnant (has a negative urine pregnancy result prior to randomization), not breastfeeding, and at least one of the following conditions applies:
•a. Not a woman of childbearing potential (WOCBP)
•b. 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 treatment
•6\. Documentation of absence of an obstructing lesion on upper GI series with contrast or upper endoscopy performed at some time before the Run\-in Period (Visit 2\) but after the appearance of symptoms that led to the diagnosis of DG
•7\. At least 2 vomiting episodes during the 2 weeks prior to screening (Visit 1\), as ascertained by participant history

Exclusion Criteria

•1\. Symptomatic Irritable Bowel Syndrome at Screening (Visit 1\)
•2\. Small intestinal bacterial overgrowth (SIBO) at Screening (Visit 1\)
•3\. Participants who are actively experiencing anorexia nervosa, binge\-eating, bulimia, or other eating disorder at the time of Screening (Visit 1\) are excluded regardless of when diagnosis was established.
•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 sensitivity
•5\. History of belching disorders, other nausea and vomiting disorders (eg, chronic nausea and vomiting syndrome, cyclic vomiting syndrome, cannabinoid hyperemesis syndrome), or rumination syndrome
•6\. History of chronic obstructive pulmonary disease or other causes of pulmonary dysfunction that have resulted in CO2 retention
•7\. 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 ULN
•9\. 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 cancer
•10\. Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube for feeding or decompression