Trial Outcomes & Findings for (Hyoscine Butylbromide) for Abdominal Pain Associated With Cramping on Demand Basis (NCT NCT00932737)

NCT ID: NCT00932737

Last Updated: 2022-05-03

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 197 participants
• Primary outcome timeframe: 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
• Results posted on: 2022-05-03

Participant Flow

This double-blind, placebo-controlled, randomized, parallel-group pilot study aimed to assess the efficacy and safety of oral doses of 20 milligram hyoscine butylbromide when used on demand for the treatment of abdominal pain associated with cramping over a treatment period of 4 weeks.

Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. 22 enrolled subjects didn't receive any trial medication

Participant milestones

Measure	Placebo Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.	Hyoscine Butylbromide (Buscopan®) 20 mg Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
Overall Study STARTED	87	88
Overall Study COMPLETED	86	87
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Placebo Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.	Hyoscine Butylbromide (Buscopan®) 20 mg Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
Overall Study Not treated in second episode	1	0
Overall Study Adverse Event	0	1

Baseline Characteristics

Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization. Participants with non-missing values were included.

Baseline characteristics by cohort

Measure	Placebo n=87 Participants Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.	Hyoscine Butylbromide (Buscopan®) 20 mg n=88 Participants Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.	Total n=175 Participants Total of all reporting groups
Age, Continuous	37.0 Years STANDARD_DEVIATION 11.3 • n=87 Participants	39.7 Years STANDARD_DEVIATION 15.0 • n=88 Participants	38.4 Years STANDARD_DEVIATION 13.3 • n=175 Participants
Sex: Female, Male Female	68 Participants n=87 Participants	62 Participants n=88 Participants	130 Participants n=175 Participants
Sex: Female, Male Male	19 Participants n=87 Participants	26 Participants n=88 Participants	45 Participants n=175 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=87 Participants	0 Participants n=88 Participants	1 Participants n=175 Participants
Race (NIH/OMB) Asian	1 Participants n=87 Participants	0 Participants n=88 Participants	1 Participants n=175 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=87 Participants	0 Participants n=88 Participants	0 Participants n=175 Participants
Race (NIH/OMB) Black or African American	33 Participants n=87 Participants	34 Participants n=88 Participants	67 Participants n=175 Participants
Race (NIH/OMB) White	52 Participants n=87 Participants	54 Participants n=88 Participants	106 Participants n=175 Participants
Race (NIH/OMB) More than one race	0 Participants n=87 Participants	0 Participants n=88 Participants	0 Participants n=175 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=87 Participants	0 Participants n=88 Participants	0 Participants n=175 Participants
Numeric pain rating scale (NPRS) for intensity of APC in episode 1	7.67 Score on a scale STANDARD_DEVIATION 1.67 • n=87 Participants	7.57 Score on a scale STANDARD_DEVIATION 1.42 • n=88 Participants	7.62 Score on a scale STANDARD_DEVIATION 1.55 • n=175 Participants
Numeric pain rating scale (NPRS) for intensity of APC in episode 2	7.86 Score on a scale STANDARD_DEVIATION 1.51 • n=72 Participants • Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization. Participants with non-missing values were included.	7.73 Score on a scale STANDARD_DEVIATION 1.44 • n=78 Participants • Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization. Participants with non-missing values were included.	7.79 Score on a scale STANDARD_DEVIATION 1.47 • n=150 Participants • Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization. Participants with non-missing values were included.

PRIMARY outcome

Timeframe: 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

Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.

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).

Outcome measures

Measure	Placebo n=87 Participants Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.	Hyoscine Butylbromide (Buscopan®) 20 mg n=88 Participants Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 1	-2.7 Score on a scale Standard Deviation 3.10	-3.1 Score on a scale Standard Deviation 3.05

PRIMARY outcome

Timeframe: 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.

Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.

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).

Outcome measures

Measure	Placebo n=72 Participants Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.	Hyoscine Butylbromide (Buscopan®) 20 mg n=78 Participants Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 2	-2.9 Score on a scale Standard Deviation 3.15	-3.2 Score on a scale Standard Deviation 3.06

PRIMARY outcome

Timeframe: 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.

Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.

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).

Outcome measures

Measure	Placebo n=87 Participants Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.	Hyoscine Butylbromide (Buscopan®) 20 mg n=88 Participants Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 1	-3.71 Score * hours Standard Deviation 2.42	-4.32 Score * hours Standard Deviation 2.27

PRIMARY outcome

Timeframe: 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.

Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.

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).

Outcome measures

Measure	Placebo n=72 Participants Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.	Hyoscine Butylbromide (Buscopan®) 20 mg n=78 Participants Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 2	-4.17 Score * hours Standard Deviation 2.51	-4.40 Score * hours Standard Deviation 2.32

PRIMARY outcome

Timeframe: At 4 hours after intake of first tablet of study medication in episode 1

Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.

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.

Outcome measures

Measure	Placebo n=87 Participants Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.	Hyoscine Butylbromide (Buscopan®) 20 mg n=88 Participants Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
Percentage of Participants With Response of "no Pain" Based on Numeric Pain Rating Scale (NPRS) in Episode 1	65.52 Percentage of participants	67.05 Percentage of participants

PRIMARY outcome

Timeframe: At 4 hours after intake of first tablet of study medication in episode 2

Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.

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.

Outcome measures

Measure	Placebo n=72 Participants Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.	Hyoscine Butylbromide (Buscopan®) 20 mg n=78 Participants Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
Percentage of Participants With Response of no Pain Based on Numeric Pain Rating Scale (NPRS) in Episode 2	69.44 Percentage of participants	71.79 Percentage of participants

PRIMARY outcome

Timeframe: At 4 hours after intake of first tablet of study medication in episode 1

Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.

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".

Outcome measures

Measure	Placebo n=87 Participants Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.	Hyoscine Butylbromide (Buscopan®) 20 mg n=88 Participants Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of "Much Better" in Episode 1	79.31 Percentage of participants	73.86 Percentage of participants

PRIMARY outcome

Timeframe: At 4 hours after intake of first tablet of study medication in episode 2

Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.

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".

Outcome measures

Measure	Placebo n=72 Participants Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.	Hyoscine Butylbromide (Buscopan®) 20 mg n=78 Participants Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of "Much Better" in Episode 2	76.39 Percentage of participants	80.77 Percentage of participants

PRIMARY outcome

Timeframe: At 4 hours after intake of first tablet of study medication in episode 1

Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.

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".

Outcome measures

Measure	Placebo n=76 Participants Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.	Hyoscine Butylbromide (Buscopan®) 20 mg n=69 Participants Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of "Very Satisfied" in Episode 1	15.79 Percentage of participants	30.43 Percentage of participants

PRIMARY outcome

Timeframe: At 4 hours after intake of first tablet of study medication in episode 2

Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.

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".

Outcome measures

Measure	Placebo n=65 Participants Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.	Hyoscine Butylbromide (Buscopan®) 20 mg n=60 Participants Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of "Very Satisfied" in Episode 2	32.31 Percentage of participants	43.33 Percentage of participants

PRIMARY outcome

Timeframe: From intake of first tablet of study medication up to 4 hours thereafter in episode 1

Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.

Time from intake of first tablet of study medication to first response of "no pain" (numeric pain rating scale (NPRS) = 0) in episode 1.

Outcome measures

Measure	Placebo n=87 Participants Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.	Hyoscine Butylbromide (Buscopan®) 20 mg n=88 Participants Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
Time to Relief in Episode 1	172.0 Minutes Interval 122.0 to 202.0	130.0 Minutes Interval 120.0 to 150.0

PRIMARY outcome

Timeframe: From intake of first tablet of study medication up to 4 hours thereafter in episode 2

Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.

Time from intake of first tablet of study medication to first response of "no pain" (numeric pain rating scale (NPRS) = 0) in episode 2.

Outcome measures

Measure	Placebo n=72 Participants Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.	Hyoscine Butylbromide (Buscopan®) 20 mg n=78 Participants Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
Time to Relief in Episode 2	150.0 Minutes Interval 120.0 to 182.0	120.0 Minutes Interval 107.0 to 158.0

PRIMARY outcome

Timeframe: From intake of first tablet of study medication up to 4 hours thereafter in each episode.

Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.

Number of tablets of study medication taken in each of the two episode.

Outcome measures

Measure	Placebo n=87 Participants Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.	Hyoscine Butylbromide (Buscopan®) 20 mg n=88 Participants Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
Number of Tablets of Study Medication Taken Episode 1	3.5 Tablets Standard Deviation 1.2	3.3 Tablets Standard Deviation 1.3
Number of Tablets of Study Medication Taken Episode 2	3.1 Tablets Standard Deviation 1.5	3.0 Tablets Standard Deviation 1.4

SECONDARY outcome

Timeframe: From the first dose of study medication until 3 days after the last dose for each episode. Up to 8 days.

Population: Treated set: This patient set includes all randomized patients who were dispensed study medication during treatment period and were documented to have taken at least one dose of investigational treatment.

Outcome measures

Measure	Placebo n=87 Participants Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.	Hyoscine Butylbromide (Buscopan®) 20 mg n=88 Participants Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
Percentage of Patients With Drug-related Adverse Events	4.6 Percentage of participants	3.4 Percentage of participants

SECONDARY outcome

Timeframe: At 4 hours after intake of first tablet of study medication in episode 1

Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.

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").

Outcome measures

Measure	Placebo n=76 Participants Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.	Hyoscine Butylbromide (Buscopan®) 20 mg n=69 Participants Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 1 Very satisfied	24 Participants	36 Participants
Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 1 Satisfied	45 Participants	29 Participants
Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 1 Dissatisfied	7 Participants	4 Participants
Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 1 Very dissatisfied	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At 4 hours after intake of first tablet of study medication in episode 2

Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.

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")

Outcome measures

Measure	Placebo n=65 Participants Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.	Hyoscine Butylbromide (Buscopan®) 20 mg n=60 Participants Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 2 Very satisfied	27 Participants	34 Participants
Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 2 Satisfied	34 Participants	25 Participants
Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 2 Dissatisfied	3 Participants	1 Participants
Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 2 Very dissatisfied	1 Participants	0 Participants

SECONDARY outcome

Timeframe: At baseline (intake of the first tablet of trial medication in the study) and day 28 (end of study visit)

Population: Treated set: This patient set includes all randomized patients who were dispensed study medication during treatment period and were documented to have taken at least one dose of investigational treatment.

Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in systolic blood pressure.

Outcome measures

Measure	Placebo n=87 Participants Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.	Hyoscine Butylbromide (Buscopan®) 20 mg n=88 Participants Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
Change From Baseline to End of Study Visit in Systolic Blood Pressure	2.52 millimetre of mercury (mmHg) Standard Deviation 11.79	-0.76 millimetre of mercury (mmHg) Standard Deviation 10.84

SECONDARY outcome

Timeframe: At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit

Population: Treated set: This patient set includes all randomized patients who were dispensed study medication during treatment period and were documented to have taken at least one dose of investigational treatment.

Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in diastolic blood pressure.

Outcome measures

Measure	Placebo n=87 Participants Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.	Hyoscine Butylbromide (Buscopan®) 20 mg n=88 Participants Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
Change From Baseline to End of Study Visit in Diastolic Blood Pressure	0.21 millimetre of mercury (mmHg) Standard Deviation 7.19	0.82 millimetre of mercury (mmHg) Standard Deviation 8.37

SECONDARY outcome

Timeframe: At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit

Population: Treated set: This patient set includes all randomized patients who were dispensed study medication during treatment period and were documented to have taken at least one dose of investigational treatment.

Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in pulse rate.

Outcome measures

Measure	Placebo n=87 Participants Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.	Hyoscine Butylbromide (Buscopan®) 20 mg n=88 Participants Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
Change From Baseline to End of Study Visit in Pulse Rate	-0.9 beats per minute (bpm) Standard Deviation 11.1	0.8 beats per minute (bpm) Standard Deviation 9.1

SECONDARY outcome

Timeframe: At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit

Population: Treated set: This patient set includes all randomized patients who were dispensed study medication during treatment period and were documented to have taken at least one dose of investigational treatment.

Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in body temperature.

Outcome measures

Measure	Placebo n=87 Participants Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.	Hyoscine Butylbromide (Buscopan®) 20 mg n=88 Participants Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
Change From Baseline to End of Study Visit in Body Temperature	-0.053 celsius Standard Deviation 0.508	-0.036 celsius Standard Deviation 0.367

SECONDARY outcome

Timeframe: At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit

Population: Treated set: This patient set includes all randomized patients who were dispensed study medication during treatment period and were documented to have taken at least one dose of investigational treatment.

Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in respiratory rate.

Outcome measures

Measure	Placebo n=87 Participants Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.	Hyoscine Butylbromide (Buscopan®) 20 mg n=88 Participants Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
Change From Baseline to End of Study Visit in Respiratory Rate	0.0 breaths per minute Standard Deviation 2.4	0.2 breaths per minute Standard Deviation 2.2

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hyoscine Butylbromide (Buscopan®) 20 mg

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=87 participants at risk Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.	Hyoscine Butylbromide (Buscopan®) 20 mg n=88 participants at risk Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks.
Metabolism and nutrition disorders Dehydration	0.00% 0/87 • From first dose until end of study visit + 3 days, up to 31 days for all-cause mortality; From first dose until 3 days after last dose for each episode, up to 8 days for (serious) adverse events. Treated set: This patient set included all randomized patients who were dispensed study medication during the treatment period and were documented to have taken at least one dose of investigational treatment. Any newly emergent abnormalities noted during the physical examination at the end of the study were recorded as adverse events and were reported together with adverse events.	1.1% 1/88 • From first dose until end of study visit + 3 days, up to 31 days for all-cause mortality; From first dose until 3 days after last dose for each episode, up to 8 days for (serious) adverse events. Treated set: This patient set included all randomized patients who were dispensed study medication during the treatment period and were documented to have taken at least one dose of investigational treatment. Any newly emergent abnormalities noted during the physical examination at the end of the study were recorded as adverse events and were reported together with adverse events.
Gastrointestinal disorders Abdominal pain	0.00% 0/87 • From first dose until end of study visit + 3 days, up to 31 days for all-cause mortality; From first dose until 3 days after last dose for each episode, up to 8 days for (serious) adverse events. Treated set: This patient set included all randomized patients who were dispensed study medication during the treatment period and were documented to have taken at least one dose of investigational treatment. Any newly emergent abnormalities noted during the physical examination at the end of the study were recorded as adverse events and were reported together with adverse events.	1.1% 1/88 • From first dose until end of study visit + 3 days, up to 31 days for all-cause mortality; From first dose until 3 days after last dose for each episode, up to 8 days for (serious) adverse events. Treated set: This patient set included all randomized patients who were dispensed study medication during the treatment period and were documented to have taken at least one dose of investigational treatment. Any newly emergent abnormalities noted during the physical examination at the end of the study were recorded as adverse events and were reported together with adverse events.
Gastrointestinal disorders Diarrhoea	0.00% 0/87 • From first dose until end of study visit + 3 days, up to 31 days for all-cause mortality; From first dose until 3 days after last dose for each episode, up to 8 days for (serious) adverse events. Treated set: This patient set included all randomized patients who were dispensed study medication during the treatment period and were documented to have taken at least one dose of investigational treatment. Any newly emergent abnormalities noted during the physical examination at the end of the study were recorded as adverse events and were reported together with adverse events.	1.1% 1/88 • From first dose until end of study visit + 3 days, up to 31 days for all-cause mortality; From first dose until 3 days after last dose for each episode, up to 8 days for (serious) adverse events. Treated set: This patient set included all randomized patients who were dispensed study medication during the treatment period and were documented to have taken at least one dose of investigational treatment. Any newly emergent abnormalities noted during the physical examination at the end of the study were recorded as adverse events and were reported together with adverse events.

Other adverse events

Adverse event data not reported

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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