Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

A 52-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis

Keywords

Gastroparesis Diabetes Mellitus diabetic gastroparesis vomiting Relamorelin Relamorelin 10 μg

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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)during the lead-in study Run-in Period at the end of the lead-in study Run-in Period,are eligible for randomization in 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.

OR

  • 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)procedures

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, with BMI > 18.5 kg/m2; 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; delayed GE by gastric emptying breath test (GEBT).
  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.

You CAN'T join if...

  • There are no exclusion criteria specific to this study; participants will be excluded from this study if any of the exclusion criteria apply at screening (Visit 1) and at the end of the Run-in Period (Visit 3) for randomization into the Treatment Period of studies RLM-MD-01 and RLM-MD-02, except as specified in the inclusion criteria

Locations

  • University of California San Diego not yet accepting patients
    La Jolla California 92037 United States
  • Medical Associates Research Group, Inc accepting new patients
    San Diego California 92123 United States
  • Clinical Applications Laboratories, Inc. not yet accepting patients
    San Diego California 92103 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Allergan
Links
Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR‐CTRegistration@Allergan.com for assistance.
ID
NCT03383146
Phase
Phase 3
Study Type
Interventional
Last Updated