(Hyoscine Butylbromide) for Abdominal Pain Associated With Cramping on Demand Basis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Abdominal Pain

Intervention / Treatment
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* Drug: Placebo
* Drug: HBB 20 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hyoscine butylbromide (HBB) 20mg 1-5 tablets per episode<br>Patient to receive 1-5 tablets containing 20mg HBB per Abdominal pain associated with cramping (APC) episode | Drug: HBB 20 mg<br>* Active drug, one to five tablets per episode<br>|
| Placebo Comparator: Placebo<br>patient to receive a tablet identical to those containing HBB and take 1-5 tablets per episode | Drug: Placebo<br>* 1-5 tablets per episode<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) 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). | 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 | 
| Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) 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). | 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. | 
| Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores 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). | 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. | 
| Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores 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). | 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. | 
| Percentage of Participants With Response of no Pain Based on Numeric Pain Rating Scale (NPRS) 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. | At 4 hours after intake of first tablet of study medication in episode 1 | 
| Percentage of Participants With Response of no Pain Based on Numeric Pain Rating Scale (NPRS) 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. | At 4 hours after intake of first tablet of study medication in episode 2 | 
| Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of Much Better 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. | At 4 hours after intake of first tablet of study medication in episode 1 | 
| Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of Much Better 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. | At 4 hours after intake of first tablet of study medication in episode 2 | 
| Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of Very Satisfied 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. | At 4 hours after intake of first tablet of study medication in episode 1 | 
| Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of Very Satisfied 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. | At 4 hours after intake of first tablet of study medication in episode 2 | 
| Time to Relief 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. | From intake of first tablet of study medication up to 4 hours thereafter in episode 1 | 
| Time to Relief 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. | From intake of first tablet of study medication up to 4 hours thereafter in episode 2 | 
| Number of Tablets of Study Medication Taken | Number of tablets of study medication taken in each of the two episode. | From intake of first tablet of study medication up to 4 hours thereafter in each episode. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Patient's global assessment of tolerability following treatment of an episode of Abdominal pain associated with cramping (APC) was based on a 4-point Verbal rating scale (VRS) in patient's response to the question, Overall, how satisfied were you with the medication in terms of side effects during this episode? (Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied). | At 4 hours after intake of first tablet of study medication in episode 1 | 
| Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 2 | Patient's global assessment of tolerability following treatment of an episode of Abdominal pain associated with cramping (APC) was based on a 4-point Verbal rating scale (VRS) in patient's response to the question, Overall, how satisfied were you with the medication in terms of side effects during this episode? (Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied) | At 4 hours after intake of first tablet of study medication in episode 2 | 
| Change From Baseline to End of Study Visit in Systolic Blood Pressure | Change from baseline (intake of the first tablet of trial medication in the study) 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 Diastolic Blood Pressure | Change from baseline (intake of the first tablet of trial medication in the study) 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 | Change from baseline (intake of the first tablet of trial medication in the study) 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 | Change from baseline (intake of the first tablet of trial medication in the study) 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 | 
| Change From Baseline to End of Study Visit in Respiratory Rate | Change from baseline (intake of the first tablet of trial medication in the study) 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 |