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

Boehringer Ingelheim197 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

197

Conditions

Abdominal Pain

Interventions

PlaceboDRUG

1-5 tablets per episode

HBB 20 mgDRUG

Active drug, one to five tablets per episode

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (19)

202.839.01014 Boehringer Ingelheim Investigational Site

Westlake Village, California, United States

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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.

Data from ClinicalTrials.gov

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202.839.01003 Boehringer Ingelheim Investigational Site

Hollywood, Florida, United States

202.839.01001 Boehringer Ingelheim Investigational Site

Jupiter, Florida, United States

202.839.01002 Boehringer Ingelheim Investigational Site

Jupiter, Florida, United States

202.839.01017 Boehringer Ingelheim Investigational Site

Rockford, Illinois, United States

202.839.01005 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

202.839.01019 Boehringer Ingelheim Investigational Site

Chevy Chase, Maryland, United States

202.839.01009 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

202.839.01004 Boehringer Ingelheim Investigational Site

Lebanon, New Hampshire, United States

202.839.01011 Boehringer Ingelheim Investigational Site

Toms River, New Jersey, United States

...and 9 more locations

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.

Time frame: 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

Time frame: 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".

Time frame: 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".

Time frame: 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".

Time frame: 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".

Time frame: 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.

Time frame: 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.

Time frame: 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.

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

Secondary Outcomes

Percentage of Patients With Drug-related Adverse Events

Time frame: 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").

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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