Trial Search Results
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04
A 52-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG) with respect to the core signs and symptoms of diabetic gastroparesis.
Stanford is currently accepting patients for this trial.
- Drug: Relamorelin
- Drug: Placebo
- Two different groups of participants may enter into the study:
- Participants must meet all the inclusion criteria at screening (Visit 1) and at the
end of the Run-in Period (Visit 3) for randomization into the Treatment Period of
RLM-MD-01 (NCT03285308) or RLM-MD-02 (NCT03426345) (including compliance with
dosing,entry of diary data into the DGSSD during the lead-in study Run-in Period).
Participants are eligible for randomization into Study RLM-MD-04 if:
- 1) They had no vomiting episodes recorded in the DGSSD and had an average daily DGSSS
≥ 12 at the end of the lead-in study Run-in Period.
- 2) They had vomiting episodes recorded in the DGSSD but had an average daily DGSSS of
≥ 12 and < 16 at the end of the lead-in study Run-in Period.
In the current study, these "rollover participants" will enter the study at Visit 1
(Randomization); they will not undergo Screening (Visit -2) or the Run-in Visit (Visit -1)
Patients who undergo screening and run-in procedures in Study RLM-MD-04 are "de novo
participants". To be eligible for randomization in the current study, de novo participants
must meet all Screening and Run-in Period criteria for Study RLM-MD-04, including:
1. At Screening, be male or female age 18 years and older, T1DM or T2DM with controlled
and stable blood glucose levels and HbA1c ≤ 11%; symptoms suggestive of DG for at
least 3 months (one of which must be nausea), with mechanical obstruction of the GI
tract as the cause of symptoms having been ruled out;
2. After Run-in Period: Evidence of compliance during the Run-in Period with the use of
the electronic hand-held device for entry of data, with twice daily SC injections of
the study treatment, and no treatment with GI promotility agents; a score of ≥ 12 for
the average of the daily DGSSS measured during the Run-in Period, delayed GE by
gastric emptying breath test (GEBT).
- Participants with a know allergy or hypersensitivity to the study treatments and their
excipients (i.e., mannitol or phenol)
- Rollover participants will be excluded from this study if any of the lead-in study
exclusion criteria apply at Screening and at the end of the Run-in Period for
randomization into the Treatment Period of the study
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study