Allergan - RLM-MD-01 Clinical Research Study
A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis
Patient Benefits
Patients who screen and then enroll in the study will receive:
- Study drug (active, comparator or placebo), lab work, visits are included at no cost.
- Patients will be reimbursed $50.00 per completed study visit for transportation costs with a maximum benefit of $550 for the course of the study.
Study Duration for Patients
The total study duration is approximately 18-weeks which consists of approximately 7 visits during the course of the study.
The study consists of three periods:
- Screening Period (3 to 6 weeks before the treatment starts) to see if you are eligible to participate in the study.
- Run-In Period (2 weeks). This Study Treatment period will check subject’s symptoms through an eDiary.
- Study Treatment Period (12 weeks) This study treatment period will consist of treatment with either study drug or placebo (double-blind).
The study may also have some unplanned visits, most commonly for repeat lab work.
Relamorelin
Relamorelin is an investigational synthetic peptide medication.
Inclusion Criteria
The following must be met in order to qualify for the study.
- Diagnosis of Type 1 or Type 2 diabetes mellitus
- Meet the per protocol criteria of diabetic gastroparesis
- Compliance with diary
- Compliance with the per protocol study treatment dosing instructions
Exclusion Criteria
Patients with any of the following are ineligible to enroll in the study.
- Currently receiving nutrition intravenously, by nasogastric tube, or other feeding tube
- History of an eating disorder (eg, anorexia nervosa, binge-eating, bulimia) in the past 5 years
- Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity
- History of gastrointestinal disorders that may be similar to gastroparesis
- Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus
** Other eligibility criteria exist to enroll in the study. Study eligibility requirements are subject to change. STAT Research and Dr. Ordway reserve the right to exclude patients who do qualify for other reasons. Enrollment is limited and may be closed at any time without prior notice.
Study Location
630 N. Main St.
Suite 210
Springboro, OH 45066
See if you Qualify!
Complete the form below and a research coordinator will contact you regarding phone or in-person pre-screening.
1-833-STAT-833
Study Investigator
Dr. Joshua Ordway, M.D.
Principal Investigator
Dr. Ordway is a graduate of Princeton University and received his Doctorate from Wright State University Boonshoft School of Medicine. In his practice, he sees a variety of conditions and has a diverse background in treating conditions related to dermatology, rheumatology, geriatrics, joint injections, sports medicine, and multiple other therapeutic areas.
