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NCT01394055 · ClinicalTrials.gov registry record · Phase 1
Study to Assess Pharmacodynamics of RM-131 in Patients With Diabetic Gastroparesis
A Phase 1 study of Gastroparesis and Gastrointestinal Motility Disorder, sponsored by Motus Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT01394055: Completed Phase 1 study of Gastroparesis and Gastrointestinal Motility Disorder, sponsored by Motus Therapeutics.
NCT01394055 is a Phase 1 study of Gastroparesis and Gastrointestinal Motility Disorder that has completed, run by Motus Therapeutics. The registered enrollment target is 20 participants, below the 302-participant average among 44 other Gastroparesis trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01394055, a Phase 1 study of Gastroparesis and Gastrointestinal Motility Disorder, has completed, sponsored by Motus Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the pharmacodynamic (PD) and pharmacokinetic (PK) profile and the safety and tolerability of RM-131 in patients with diabetes mellitus and delayed gastric emptying.
Primary Outcome
Change from baseline in gastric half-emptying time by scintigraphy (solids and liquids)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG RM-131
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-07 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
What the finished NCT01394055 record still lists
NCT01394055 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 302-participant average among 44 other Gastroparesis trials with a reported enrollment target (93% lower).
The record links to 4 conditions, with Gastroparesis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01394055 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT01394055 about?
NCT01394055 is a clinical study titled "Study to Assess Pharmacodynamics of RM-131 in Patients With Diabetic Gastroparesis". The purpose of this study is to evaluate the pharmacodynamic (PD) and pharmacokinetic (PK) profile and the safety and tolerability of RM-131 in patients with diabetes mellitus and delayed gastric emptying.
What is the current status of trial NCT01394055?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2011-07. Estimated completion is 2012-12.
What conditions does trial NCT01394055 study?
This clinical trial studies the following conditions: Gastroparesis, Gastrointestinal Motility Disorder, Diabetes Mellitus Type 1 and 2, Diabetes Mellitus Complications.
What interventions are being tested in trial NCT01394055?
The interventions under investigation include: Placebo (DRUG), RM-131 (DRUG).
Who is sponsoring clinical trial NCT01394055?
This trial is sponsored by Motus Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01394055 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01394055's enrollment target sits among peer trials
20 34th of 44 higher than 9 of 44 other Gastroparesis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastroparesis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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