A Double-blind, Placebo-controlled, Randomized, Parallel-group Pilot Study of the Efficacy and Safety of Oral Doses of 20 mg Hyoscine Butylbromide When Used on Demand for the Treatment of Self-reported Functional Abdominal Pain Associated With Cramping
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 197
- 试验地点
- 19
- 主要终点
- Number of Tablets of Study Medication Taken
研究概览
简要总结
The primary objective of this pilot study is to assess effects of Hyoscine Butylbromide (HBB) 20 mg in comparison to placebo, when used as needed, as measured by the subject's assessment of intensity of abdominal pain associated with cramping (APC) in the treatment of two episodes.
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
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
- •History of recurrent abdominal pain with cramping (APC) for at least three months.
- •Recorded at least two episodes of APC of at least "moderate" intensity (i.e., 5 or above on a 0-10 point scale) lasting one hour in the eDiary during the run-in period.
排除标准
- •Experiencing daily episode of APC during Run-in period Active gastrointestinal disease during the past 12 months including malignancy, inflammatory bowel disease, celiac disease or complete or partial bowel obstruction and who have undergone major gastrointestinal surgery with the past 12 months (patients with history of appendectomy, cholecystectomy, bilateral tubal ligation and c-section within past 12 months are allowed in the study).
研究组 & 干预措施
Hyoscine butylbromide (HBB) 20mg 1-5 tablets per episode
Patient to receive 1-5 tablets containing 20mg HBB per Abdominal pain associated with cramping (APC) episode
干预措施: HBB 20 mg (Drug)
Placebo
patient to receive a tablet identical to those containing HBB and take 1-5 tablets per episode
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Tablets of Study Medication Taken
时间窗: From intake of first tablet of study medication up to 4 hours thereafter in each episode.
Number of tablets of study medication taken in each of the two episode.
Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of "Much Better" in Episode 1
时间窗: At 4 hours after intake of first tablet of study medication in episode 1
At episode 1, after the intake of first tablet of study medication, the patient then responded to the question of "Compared to just before you took the first tablet of study medication, how would you rate your abdominal pain associated with cramping now?" based on the Patient global impression of change (PGI-C), using the available responses: "Much better", "Somewhat better", "A little better", "No change", "A little worse", and "Somewhat worse".
Time to Relief in Episode 2
时间窗: From intake of first tablet of study medication up to 4 hours thereafter in episode 2
Time from intake of first tablet of study medication to first response of "no pain" (numeric pain rating scale (NPRS) = 0) in episode 2.
Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 1
时间窗: At baseline (prior to intake of first tablet of study medication for episode 1) and 15 minutes(min), 30min, 45min, 1 hour(h), 1h30min, 2h, 2h30min, 3h, 3h30min, and 4h thereafter.
The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
Percentage of Participants With Response of "no Pain" Based on Numeric Pain Rating Scale (NPRS) in Episode 1
时间窗: At 4 hours after intake of first tablet of study medication in episode 1
The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Responses of "no pain" (NPRS = 0) based on the 0 to 10 point NPRS scale were summarized.
Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 2
时间窗: At baseline (prior to intake of first tablet of study medication in episode 2) until 4 hours thereafter or until the patient had responded that their pain was absent, up to 4 hours.
The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
Percentage of Participants With Response of no Pain Based on Numeric Pain Rating Scale (NPRS) in Episode 2
时间窗: At 4 hours after intake of first tablet of study medication in episode 2
The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Responses of "no pain" (NPRS = 0) based on the 0 to 10 point NPRS scale were summarized.
Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 1
时间窗: At baseline (prior to intake of first tablet of study medication in episode 1) until 4 hours thereafter or until the patient had responded that their pain was absent, up to 4 hours
The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 2
时间窗: At baseline (prior to intake of first tablet of study medication for episode 2) and 15 minutes(min), 30min, 45min, 1 hour(h), 1h30min, 2h, 2h30min, 3h, 3h30min, and 4h thereafter.
The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of "Very Satisfied" in Episode 2
时间窗: At 4 hours after intake of first tablet of study medication in episode 2
At episode 2, after the intake of first tablet of study medication, the patient then responded to the question of "Overall, how satisfied were you with the medication in terms of effectiveness for this episode?" based on the 4-point Verbal rating scale (VRS) using the available response: "Very Satisfied", "Satisfied", "Dissatisfied", and "Very Dissatisfied".
Time to Relief in Episode 1
时间窗: From intake of first tablet of study medication up to 4 hours thereafter in episode 1
Time from intake of first tablet of study medication to first response of "no pain" (numeric pain rating scale (NPRS) = 0) in episode 1.
Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of "Much Better" in Episode 2
时间窗: At 4 hours after intake of first tablet of study medication in episode 2
At episode 2, after the intake of first tablet of study medication, the patient then responded to the question of "Compared to just before you took the first tablet of study medication, how would you rate your abdominal pain associated with cramping now?" based on the Patient global impression of change (PGI-C), using the available responses: "Much better", "Somewhat better", "A little better", "No change", "A little worse", and "Somewhat worse".
Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of "Very Satisfied" in Episode 1
时间窗: At 4 hours after intake of first tablet of study medication in episode 1
At episode 1, after the intake of first tablet of study medication, the patient then responded to the question of "Overall, how satisfied were you with the medication in terms of effectiveness for this episode?" based on the 4-point Verbal rating scale (VRS) using the available response: "Very Satisfied", "Satisfied", "Dissatisfied", and "Very Dissatisfied".
次要结局
- Percentage of Patients With Drug-related Adverse Events(From the first dose of study medication until 3 days after the last dose for each episode. Up to 8 days.)
- Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 1(At 4 hours after intake of first tablet of study medication in episode 1)
- Change From Baseline to End of Study Visit in Systolic Blood Pressure(At baseline (intake of the first tablet of trial medication in the study) and day 28 (end of study visit))
- Change From Baseline to End of Study Visit in Respiratory Rate(At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit)
- Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 2(At 4 hours after intake of first tablet of study medication in episode 2)
- Change From Baseline to End of Study Visit in Diastolic Blood Pressure(At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit)
- Change From Baseline to End of Study Visit in Pulse Rate(At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit)
- Change From Baseline to End of Study Visit in Body Temperature(At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit)