Phase 2 Study to Evaluate Safety & Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis
NCT ID: NCT01571297
Last Updated: 2016-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
204 participants
INTERVENTIONAL
2012-04-30
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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RM-131
RM-131
Double blind RM-131 will be studied with various doses and regimens from 10 to 100 μg for 35 days.
Placebo
Placebo
Placebo given subcutaneously for 35 days
Interventions
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RM-131
Double blind RM-131 will be studied with various doses and regimens from 10 to 100 μg for 35 days.
Placebo
Placebo given subcutaneously for 35 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Motus Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Development Officer
Role: STUDY_DIRECTOR
Rhythm Pharmaceuticals, Inc.
Locations
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Dothan, Alabama, United States
Tucson, Arizona, United States
North Little Rock, Arkansas, United States
Concord, California, United States
Lomita, California, United States
Los Angeles, California, United States
Torrance, California, United States
Hialeah, Florida, United States
Inverness, Florida, United States
Miami, Florida, United States
West Palm Beach, Florida, United States
Wichita, Kansas, United States
Monroe, Louisiana, United States
Chevy Chase, Maryland, United States
Boston, Massachusetts, United States
Farmington Hills, Michigan, United States
Jackson, Mississippi, United States
Lebanon, New Hampshire, United States
Albuquerque, New Mexico, United States
Morehead City, North Carolina, United States
Raleigh, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Portland, Oregon, United States
Chattanooga, Tennessee, United States
Germantown, Tennessee, United States
Dallas, Texas, United States
Lubbock, Texas, United States
Burke, Virginia, United States
Norfolk, Virginia, United States
Countries
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References
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Camilleri M, Lembo A, McCallum R, Tourkodimitris S, Kemps L, Miller MB, Bertelsen K, Iacob A. Overall safety of relamorelin in adults with diabetic gastroparesis: Analysis of phase 2a and 2b trial data. Aliment Pharmacol Ther. 2020 Jun;51(11):1139-1148. doi: 10.1111/apt.15711. Epub 2020 Apr 17.
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.
Other Identifiers
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RM-131-004
Identifier Type: -
Identifier Source: org_study_id
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