NCT06899217已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Idiopathic Gastroparesis.
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 416
- 试验地点
- 139
- 主要终点
- The effect of CIN-102 to significantly decrease nausea severity as compared to baseline based on the average ANMS GCSI-DD Nausea Subscale Score.
研究概览
简要总结
The goal of this clinical trial is to evaluate if the study drug CIN-102 (deudomperidone) can help to decrease nausea severity associated with idiopathic gastroparesis severity in adult subjects.
The main questions it aims to answer are:
- To evaluate the efficacy of CIN-102 on symptoms of gastroparesis when given to patients with idiopathic gastroparesis compared to a placebo
- To evaluate the safety of CIN-102 when given to patients with idiopathic gastroparesis compared to a placebo
Participants will go through the following schedule:
-
Pre-screening (1 visit)
-
Screening & Lead-In (1-2 visits)
-
Will complete a Gastric Emptying Breath Test (GEBT)
-
Will complete daily diary and other Patient Reported Outcomes (PROs) as described in the protocol to assess eligibility for continued study participation.
-
Lead-In Period (1 visit)
-
12-week treatment period (7 visits)
-
Study drug taken twice daily by mouth
-
Will complete daily diaries and other PROs as described in protocol
-
1 week follow-up (1 visit)
Researchers will compare the effects of the following treatments:
- 15 mg CIN-102, taken orally BID for 12 weeks
- 10 mg CIN-102, taken orally BID for 12 weeks
- Placebo for CIN-102, taken orally BID for 12 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is a male or female ≥18 years of age;
- •Has a current diagnosis of gastroparesis defined by the following:
- •Persistent gastrointestinal (GI) symptoms that, in the opinion of the Investigator, are consistent with gastroparesis within 6 months prior to Screening; and
- •Documented delayed gastric emptying as determined by gastric emptying breath test (GEBT) at Visit
- •Body mass index between 17 and 49 kg/m2, inclusive;
- •If receiving treatment with a Food and Drug Administration (FDA)-approved and marketed glucagon-like peptide-1 receptor agonist (GLP-1RA) for weight loss or reduce risk of major adverse cardiovascular events, and/or, receiving any other agent(s) taken for weight loss, subjects may be considered for the study if ALL of the following criteria are satisfied:
- •Is not taking the agent(s) for the management of diabetes or blood glucose;
- •Has been on a stable dose of the agent(s) for at least 3 months before Screening and is expected to maintain the same dose throughout the study, including during GEBT;
- •Is tolerating the agent(s) well, according to the Investigator's judgment;
- •In the opinion of the Investigator, the study-qualifying signs/symptoms of gastroparesis are NOT solely due to the the agent(s); and
- •Symptoms of gastroparesis were present before starting the agent(s).
- •-------------------------------------------------------------------------
排除标准
- •Has a known primary cause of gastroparesis (eg, diabetes, surgery; acute, ongoing, or active viral illness; cancer, medications, musculoskeletal or connective tissue disorders [eg, scleroderma, systemic lupus erythematosus], or other neurologic disorder [eg, Parkinson's disease], postural orthostatic tachycardia syndrome (POTS), etc.]);
- •Has a current diagnosis of Type 1 or Type 2 diabetes, according to the American Diabetes Association. Pre-diabetes is not exclusionary;
- •Has been hospitalized for gastroparesis or malnutrition within 3 months prior to Screening;
- •Has a known or suspected GI mechanical obstruction (eg, peptic stricture) as documented by upper GI endoscopy, upper GI radiographic series, plain film abdomen X-ray, or computed tomography (CT) in the past 2 years prior to Randomization;
- •Has a history of pyloric injection of botulinum toxin within 6 months of Screening or planned injection(s) during the study;
- •Has any history of pyloroplasty, pyloromyotomy, or gastric peroral endoscopic myotomy (G-POEM) procedure;
- •Has a history of gastric surgery;
- •Has a history of or current diagnosis of intestinal malabsorption, recurrent or chronic pancreatitis, or other pancreatic exocrine disease;
- •Has a history of severe and refractory constipation;
- •Has a history or evidence of clinically significant arrhythmia;
- •Currently receiving parenteral feeding or presence of a nasogastric or other gastric enteral tube (e.g. percutaneous endoscopic gastrostomy [PEG] or percutaneous endoscopic jejunostomy [PEJ] tube) for feeding or decompression; Note: patients receiving enteral feeding via a jejunostomy tube may be included if, in the opinion of the Investigator, the patient is also taking substantial oral solid intake and are not primarily dependent on enteral nutrition
- •Has a substance use disorder or a positive alcohol or positive drug screen.
研究组 & 干预措施
CIN-102: 15mg
Experimental
15 mg CIN-102, taken orally BID for 12 weeks
干预措施: CIN-102 Dose 15mg (Drug)
CIN-102: 10mg
Experimental
10 mg CIN-102, taken orally BID for 12 weeks
干预措施: CIN-102 Dose 10mg (Drug)
Placebo for CIN-102
Placebo Comparator
Placebo for CIN-102, taken orally BID for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
The effect of CIN-102 to significantly decrease nausea severity as compared to baseline based on the average ANMS GCSI-DD Nausea Subscale Score.
时间窗: Over the last 2 weeks of the 12-week Treatment Period as compared to Baseline
The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) Nausea Subscale Scores will be averaged into a single value that ranges 0-4 (0 for no symptom and 4 for very severe).
次要结局
- The effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline(Over the final 6 weeks of the 12-week Treatment Period as compared to Baseline)
- The percentage of subjects who are identified as responders, defined as archiving an average ≥1 point reduction from baseline on each of ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, and individual subscale scores(Over the last 2 weeks of the 12-week Treatment Period as well as over the entire Treatment Period)
- The percentage of subjects who are identified as responders, defined as archiving an average ≥0.5 point reduction from baseline on each of ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, and individual subscale scores(Over the last 2 weeks of the 12-week Treatment Period as well as over the entire Treatment Period)
- The percentage of subjects who are identified as responders, defined as achieving an average ≥30% reduction from baseline for each of following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores(Over the last 2 weeks of the 12-week Treatment Period as well as over the entire Treatment Period)
- The percentage of symptom-free days in the ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores.(Over the 12-week Treatment Period)
- The percentage of symptomatic weeks for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores(Over the final 6 weeks of the 12-week Treatment Period)
- The percentage of mild, moderate, severe and very severe symptomatic weeks for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores(Over the 12-week Treatment Period)
- The Patient Global Impression of Change (PGIC) value(Over the final 6 weeks of the 12-week Treatment Period)
- The Patient Global Impression of Severity (PGIS) value(Over the final 6 weeks of the 12-week Treatment Period)
- The effect of CIN-102 to significantly decrease nausea severity as compared to baseline based on the average ANMS GCSI-DD Nausea Subscale Score.(Over the final 6 weeks of the 12-week Treatment Period as compared to Baseline)
- The percentage of subjects identified as responders, defined as an average ≥0.5 reduction from baseline on each of ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, vomiting severity scores(Over the last 6 weeks of the 12-week Treatment Period)
- The percentage of subjects identified as responders, defined as achieving ≥30% reduction from baseline for each: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, vomiting severity scores(Over the final 6 weeks of the 12-week Treatment Period)
- The percentage of symptom-free days in the ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores(Over the final 6 weeks of the 12-week Treatment Period)
- The percentage of moderate, severe and very severe symptomatic weeks for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores(Over the final 6 weeks of the 12-week Treatment Period)
- To assess the safety of CIN-102 compared to placebo in adult subjects with idiopathic gastroparesis from the time of informed consent until the EOS(Over the 12-week Treatment Period)
- The effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline(Over the final 6 weeks of the 12-week Treatment Period as compared to Baseline)
- The percentage of subjects who are identified as responders, defined as archiving an average ≥1 point reduction from baseline on each of ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, and individual subscale scores(Over the last 2 weeks of the 12-week Treatment Period as well as over the entire Treatment Period)
- The percentage of subjects who are identified as responders, defined as archiving an average ≥0.5 point reduction from baseline on each of ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, and individual subscale scores(Over the last 2 weeks of the 12-week Treatment Period as well as over the entire Treatment Period)
- The percentage of subjects who are identified as responders, defined as achieving an average ≥30% reduction from baseline for each of following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores(Over the last 2 weeks of the 12-week Treatment Period as well as over the entire Treatment Period)
- The percentage of symptom-free days in the ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores.(Over the 12-week Treatment Period)
- The percentage of symptomatic weeks for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores(Over the final 6 weeks of the 12-week Treatment Period)
- The percentage of mild, moderate, severe and very severe symptomatic weeks for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores(Over the 12-week Treatment Period)
- The Patient Global Impression of Change (PGIC) value(Over the final 6 weeks of the 12-week Treatment Period)
- The Patient Global Impression of Severity (PGIS) value(Over the final 6 weeks of the 12-week Treatment Period)
- The effect of CIN-102 to significantly decrease nausea severity as compared to baseline based on the average ANMS GCSI-DD Nausea Subscale Score.(Over the final 6 weeks of the 12-week Treatment Period as compared to Baseline)
- The percentage of subjects identified as responders, defined as an average ≥0.5 reduction from baseline on each of ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, vomiting severity scores(Over the last 6 weeks of the 12-week Treatment Period)
- The percentage of subjects identified as responders, defined as achieving ≥30% reduction from baseline for each: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, vomiting severity scores(Over the final 6 weeks of the 12-week Treatment Period)
- The percentage of symptom-free days in the ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores(Over the final 6 weeks of the 12-week Treatment Period)
- The percentage of moderate, severe and very severe symptomatic weeks for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores(Over the final 6 weeks of the 12-week Treatment Period)
- To assess the safety of CIN-102 compared to placebo in adult subjects with idiopathic gastroparesis from the time of informed consent until the EOS(Over the 12-week Treatment Period)
- The effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline(Over the last 2 weeks of the 12-week Treatment Period as compared to Baseline)
- The percentage of symptomatic weeks for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores(Over the 12-week Treatment Period)
- The Patient Global Impression of Change (PGIC) value(Over the 12-week Treatment Period)
- The Patient Global Impression of Severity (PGIS) value(From baseline to Week 12)
研究者
研究点 (139)
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