CTRI/2019/03/018134Other3 期
A 52-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
- Allergan
- 入组人数
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1)Two different groups of participants may enter into the study:
- •2)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) (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:
- •a) They had no vomiting episodes recorded in the DGSSD and had an average daily DGSSS greater than or equals to 12 at the end of the lead-in study Run-in Period.
- •b) They had vomiting episodes recorded in the DGSSD but had an average daily DGSSS of greaterthan or equals to 12 and less than 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 greater than 18.5 kg/m2; T1DM or T2DM with controlled and stable blood glucose levels and HbA1c less than or equals to 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 greater than or equals to 12 for the average of the daily DGSSS measured during the Run-in Period.
排除标准
- •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
研究者
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