A Double-Blind Superiority Randomized Controlled Trial Comparing Acotiamide vs Itopride for Functional Dyspepsia Management
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 368
- 主要终点
- : Overall Treatment Effect (OTE)
研究概览
简要总结
This study is a randomized, double-blinded trial that will compare the effectiveness of two medications, acotiamide and itopride, in treating Functional Dyspepsia. Functional Dyspepsia causes uncomfortable symptoms arising from the gastro-duodenal region, such as fullness after meals, early satiation, stomach pain, and burning.
The primary aim of this trial is to determine whether acotiamide is superior to itopride-specifically by a margin of 15%-at improving these meal-related digestive symptoms.
Participants will be involved in the study for a total of 5 weeks. The study begins with a 7-day baseline period where participants will track their symptoms daily.
Following the baseline period, participants will be randomly assigned to receive either 100mg of acotiamide three times a day or 50mg of itopride three times a day.
The treatment phase will last for 4 weeks, during which participants will take the medication before meals on an empty stomach.
Participants will continue to track their symptoms daily and will complete questionnaires about their overall treatment effect and quality of life at follow-up visits.
详细描述
Functional Dyspepsia (FD) is defined as gastro-duodenal symptoms occurring without any underlying systemic or metabolic disease, affecting an estimated 8.4% of the global population. Both acotiamide and itopride are established, commercially available medications known to be efficacious in managing FD. However, there is currently no direct comparison between the two drugs to help establish a universally accepted standard of care.
This study is designed as a single-center, randomized, double-blind superiority trial to be conducted at the Aga Khan University Hospital in Karachi, Pakistan. The trial seeks to enroll 368 participants aged 18 to 70 who meet the ROME IV criteria for FD, specifically Postprandial Distress Syndrome (PDS).
Methodology & Procedures:
Baseline Phase: Participants will undergo a 7-day baseline period in which they will discontinue any current gastrointestinal medications to clear residual effects.
Randomization & Blinding: Participants will be randomized via a computer-generated program in a 1:1 ratio to one of two treatment arms. To ensure double-blinding, the hospital pharmacy will encapsulate both acotiamide and itopride into identical opaque capsules, making them indistinguishable in taste, smell, and appearance.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients experiencing bothersome post-prandial fullness or bothersome early satiation at least three days a week.
- •Symptom onset must have occurred six months prior to diagnosis, and symptoms must have been present for at least the past three months.
- •No evidence of organic, systemic, or metabolic disease based on clinical investigations and endoscopy.
- •Patients with co-existing symptoms of Epigastric Pain Syndrome (EPS) are included only if the symptoms causing the most distress are meal-related.
- •Individuals who have already tested negative for H. pylori (separate tests will not be conducted for the study).
排除标准
- •Patients with an identifiable organic disease that can explain their symptoms, such as peptic ulcer, GERD, or chronic pancreatitis.
- •Patients with a history of gastrointestinal surgery.
- •History of malignancy in the past five years.
- •Patients having major psychiatric or depressive disorders.
- •Patients with a history of drug or alcohol abuse.
- •Patients with advanced chronic kidney disease.
- •Patients with uncontrolled diabetes (HbA1c >8).
- •Patients with uncontrolled hypertension.
- •Patients diagnosed with Irritable Bowel Syndrome.
- •Pregnant or lactating women.
- •Patients who have used antibiotics, opioids, or any other medication that -affects gastrointestinal function in the past 4 weeks.
- •H. pylori positive patients.
- •Patients who cannot fill out scales or record their symptoms.
研究组 & 干预措施
Acotiamide Arm
Participants randomized to this group will receive 100 mg of acotiamide thrice daily, before meals on an empty stomach for 4 weeks.
干预措施: Acotiamide (Drug)
Itopride Arm
Participants randomized to this group will receive 50 mg of itopride thrice daily, before meals on an empty stomach for 4 weeks.
干预措施: itopride (Drug)
结局指标
主要结局
: Overall Treatment Effect (OTE)
时间窗: Week 1 and Week 4.
The primary outcome is evaluated using the Overall Treatment Effect (OTE) questionnaire to determine if acotiamide is superior to itopride in improving symptoms of functional dyspepsia. Participants will be asked to compare their current symptoms to their baseline using a 7-point Likert scale. The scale ranges from a minimum value of 1, which denotes "extremely improved compared to baseline," to a maximum value of 7, which denotes "extremely aggravated compared to baseline". Therefore, higher scores on this scale indicate a worse outcome. Patients selecting options 1 through 3 on the OTE scale will be considered responders to the treatment, while those selecting 4 through 7 will be considered non-responders.
次要结局
- Quality of Life: Assessing changes in the patient's disease-specific quality of life.(Recorded on day 7 (end of baseline) and at the end of week 4)
- Symptom Severity: Participants will evaluate the severity of 9 specific upper gastrointestinal symptoms(Throughout the 4-week period)
研究者
SHAHAB ABID
Professor of Medicine (Gastroenterology)
Aga Khan University