Protocol PT 11-29: Randomized, Open-label, Cross-over Pilot Study to Evaluate and Compare Two Omeprazole Containing Products for Relief of Frequent Heartburn
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 48
- 主要终点
- Time-to-onset of Heartburn Relief
研究概览
简要总结
This study will evaluate a single ingredient product (omeprazole 20 mg) with a combination product capsule (omeprazole 20 mg + sodium bicarbonate 1100 mg) in participants with frequent heartburn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Females of reproductive potential must demonstrate a negative urine pregnancy test and agree to use an acceptable method of birth control
- •Suffer from frequent heartburn
- •Refrain from taking non-study medicine or treatment for heartburn for the duration of the study
- •Be free of any clinically significant disease that requires a physician's care
- •Read and understand English
排除标准
- •Any significant medical condition which is a contraindication to the use of omeprazole or sodium bicarbonate
- •Known hypersensitivity to the study drugs or any components
- •Experiencing any of the following: trouble or pain with swallowing food, vomiting with blood, bloody or black stools
- •Participation in another investigational study within 4 weeks prior to the screening visit.
研究组 & 干预措施
Omeprazole 20 mg + Sodium Bicarbonate 1100 mg
Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg once a day for 4 days.
干预措施: Omeprazole 20 mg + Sodium Bicarbonate 1100 mg (Drug)
Omeprazole 20 mg + Sodium Bicarbonate 1100 mg
Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg once a day for 4 days.
干预措施: Omeprazole 20 mg (Drug)
Omeprazole 20 mg
Participants will receive omeprazole 20 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.
干预措施: Omeprazole 20 mg + Sodium Bicarbonate 1100 mg (Drug)
Omeprazole 20 mg
Participants will receive omeprazole 20 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.
干预措施: Omeprazole 20 mg (Drug)
结局指标
主要结局
Time-to-onset of Heartburn Relief
时间窗: Start of treatment until onset of heartburn relief, up to 24 hours
Time-to-onset of heartburn relief was defined as earliest time following start of treatment that participant experienced a reduction of at least one grade from baseline in the severity of heartburn. Severity of heartburn was evaluated by the participant using the 4-point Likert Scale, which rated heartburn severity as follows: Absent (0): Heartburn is not present. Mild (1): Heartburn did not last long or was easily tolerated. Moderate (2): Heartburn caused discomfort and interrupted usual activities. Severe (3): Heartburn caused great interference with usual activities and may have been incapacitating.
次要结局
- Number of Participants Preferring Each Treatment for Heartburn Relief: Final Subjective Questionnaire(At end of study (approx. Study Day 40))
- Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time(Start of treatment until onset of heartburn relief, up to 72 hours)
- Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire(End of treatment period 1 and end of treatment period 2)
- Number of Participants Preferring Each Treatment for Heartburn Control: Final Subjective Questionnaire(At end of study (approx. Study Day 40))
- Number of Participants Preferring Each Treatment Overall: Final Subjective Questionnaire(At end of study (approx. Study Day 40))