| Trial ID: | L4865 |
| Source ID: | NCT01394055
|
| Associated Drug: |
Rm-131
|
| Title: |
Study to Assess Pharmacodynamics of RM-131 in Patients With Diabetic Gastroparesis
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus Type 1 and 2|Diabetes Mellitus Complications|Gastroparesis|Gastrointestinal Motility Disorder
|
| Interventions: |
DRUG: RM-131|DRUG: Placebo
|
| Outcome Measures: |
Primary: Pharmacodynamic (PD) effects of RM-131 on gastric emptying, Change from baseline in gastric half-emptying time by scintigraphy (solids and liquids), Day 1 at baseline vs Day 1 at 6 hours after dosing in Period 1 and Day 1 at baseline vs Day 1 at 6 hours after dosing in Period 2 | Secondary: Safety and tolerability of RM-131, Number of participants with adverse events, Day 1 and 2 after dosing in Period 1 and Day 1 and 2 after dosing in Period 2|Pharmacokinetics (PK) of RM-131, Median T-max of RM-131 levels in patients with type 2 diabetes mellitus, Day 1 at baseline vs Day 1 at 6 hours after dosing in Period 1 and Day 1 at baseline vs Day 1 at 6 hours after dosing in Period 2
|
| Sponsor/Collaborators: |
Sponsor: Motus Therapeutics, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
20
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-07
|
| Completion Date: |
2012-12
|
| Results First Posted: |
|
| Last Update Posted: |
2016-09-22
|
| Locations: |
Mayo Clinic, Rochester, Minnesota, 55905, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01394055
|
