Phase 2 Study to Evaluate Safety & Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis

Tracking Information
First Submitted Date ICMJE	April 2, 2012
First Posted Date ICMJE	April 5, 2012
Last Update Posted Date	September 23, 2016
Study Start Date ICMJE	April 2012
Actual Primary Completion Date	August 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 4, 2012)	Effect of RM-131 on gastric emptying time [ Time Frame: Screening and Day 28 ]; Change from baseline in gastric half-emptying time (t½)
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01571297 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: April 4, 2012)	Effect of RM-131 on symptoms of gastroparesis [ Time Frame: Baseline, daily for 28 days, and Day 35 ]Longitudinal change from baseline over time in daily symptom scores from a self administered daily symptom diary; Safety and tolerability of RM-131 [ Time Frame: From Screening through Day 35 ]Assessment of adverse events and clinical laboratory evaluations
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Phase 2 Study to Evaluate Safety & Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis
Official Title ICMJE	A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis
Brief Summary	The purpose of this study is to evaluate the effects of RM-131 on gastric emptying, gastroparesis symptoms, and the safety and tolerability of RM-131 compared to placebo in patients with Type 1 and Type 2 diabetes mellitus and gastroparesis. The study is designed to evaluate the efficacy and safety of multiple dose regimens of RM-131. Study drug (RM-131 and placebo) will be administered subcutaneously in a blinded fashion.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition ICMJE	Diabetes Mellitus; Diabetes Mellitus Complications; Gastroparesis
Intervention ICMJE	Drug: RM-131 Double blind RM-131 will be studied with various doses and regimens from 10 to 100 μg for 35 days.; Drug: Placebo Placebo given subcutaneously for 35 days
Study Arms	Active Comparator: RM-131 Intervention: Drug: RM-131; Placebo Comparator: Placebo Intervention: Drug: Placebo
Publications *	Lembo A, Camilleri M, McCallum R, Sastre R, Breton C, Spence S, White J, Currie M, Gottesdiener K, Stoner E; RM-131-004 Trial Group. Relamorelin Reduces Vomiting Frequency and Severity and Accelerates Gastric Emptying in Adults With Diabetic Gastroparesis. Gastroenterology. 2016 Jul;151(1):87-96.e6. doi: 10.1053/j.gastro.2016.03.038. Epub 2016 Apr 4.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: October 23, 2014)	204
Original Estimated Enrollment ICMJE; (submitted: April 4, 2012)	125
Actual Study Completion Date	September 2013
Actual Primary Completion Date	August 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Able to provide written informed consent prior to any study procedures and be willing and able to comply with study procedures.; Type 1 or Type 2 diabetes mellitus with HbA1c ≤11% at screening.; Diabetic gastroparesis defined as at least 3 months history of symptoms suggestive of gastroparesis on an ongoing basis.; Average Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) > 2.6 during Visit 2.; History of nausea and/or vomiting/emesis at least once a week during the 2 weeks prior to Visit 1.; Delayed gastric emptying confirmed at screening by abnormal gastric emptying breath test (GEBT), defined as half-emptying time (t½) > 79 minutes.; Stable concomitant medications defined as no changes in regimen for at least 2 weeks prior to Visit 2.; No use of metoclopramide, erythromycin or anti-emetics for at least 2 weeks prior to Visit 2.; Body mass index > 18 kg/m2.; Female patients must have negative serum or urine pregnancy tests and must not be lactating. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. Female patients unable to bear children must have this documented in the electronic case report form (eCRF) (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]). Post-menopausal status will be confirmed by FSH. Exclusion Criteria: Currently receiving parenteral feeding; presence of a nasogastric or other enteral tube for feeding or decompression.; History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, bariatric procedure.; History of pyloric injection of botulinum toxin within 6 months of screening.; Persistent daily vomiting.; Patients with clinical suspicion of upper gastrointestinal obstruction must have been evaluated per standard of care, and obstruction ruled out before screening.; Currently taking opiates.; Currently taking GLP-1 and amylin analogs.; Allergic or intolerant of egg, wheat, milk or algae, as these are components of the GEBT study meal.; History of anorexia nervosa, binge-eating or bulimia within 5 years.; ALT or AST > 2 X upper limit of normal during screening.; History of intestinal malabsorption or pancreatic exocrine disease.; Requires hemodialysis or has end-stage renal disease.; History of human immunodeficiency virus (HIV) infection.; Clinically significant neurologic or psychiatric disorders which are likely to impact compliance with protocol requirements.; Poor venous access or inability to tolerate venipuncture.; Participation in a clinical study within the 30 days prior to dosing in the present study.; Any other reason, which in the opinion of the Investigator, including renal, hepatic or cardiopulmonary disease, or significant acute ECG abnormalities that would confound proper interpretation of the study or expose a patient to unacceptable risk.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 75 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01571297
Other Study ID Numbers ICMJE	RM-131-004
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Motus Therapeutics, Inc.
Study Sponsor ICMJE	Motus Therapeutics, Inc.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Chief Development Officer Rhythm Pharmaceuticals, Inc.
PRS Account	Motus Therapeutics, Inc.
Verification Date	September 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP