Phase 2 N=175 Randomized Double-blind Treatment

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

Abdominal Pain

Bottom Line

View on ClinicalTrials.gov: NCT00932737 ↗

Enrolled (actual)

175

Serious AEs

0.6%

Results posted

May 2022

Primary outcome: Primary: 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; -3.1 Score on a scale — p=0.0156

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Placebo (Drug); HBB 20 mg (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Feb 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY 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; -3.1	0.0156 sig
PRIMARY 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; -3.2	0.0512
PRIMARY Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 1	-3.71; -4.32	0.0351 sig
PRIMARY Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 2	-4.17; -4.40	0.3557
PRIMARY Percentage of Participants With Response of "no Pain" Based on Numeric Pain Rating Scale (NPRS) in Episode 1	65.52; 67.05	0.831
PRIMARY Percentage of Participants With Response of no Pain Based on Numeric Pain Rating Scale (NPRS) in Episode 2	69.44; 71.79	0.557
PRIMARY Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of "Much Better" in Episode 1	79.31; 73.86	0.396
PRIMARY Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of "Much Better" in Episode 2	76.39; 80.77	0.448
PRIMARY Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of "Very Satisfied" in Episode 1	15.79; 30.43	0.030 sig
PRIMARY Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of "Very Satisfied" in Episode 2	32.31; 43.33	0.167
PRIMARY Time to Relief in Episode 1	172.0; 130.0	0.2560
PRIMARY Time to Relief in Episode 2	150.0; 120.0	0.5179
PRIMARY Number of Tablets of Study Medication Taken	3.5; 3.3; 3.1; 3.0	—
SECONDARY Percentage of Patients With Drug-related Adverse Events	4.6; 3.4	—
SECONDARY Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 1	24; 36; 45; 29; 7; 4	—
SECONDARY Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 2	27; 34; 34; 25; 3; 1	—
SECONDARY Change From Baseline to End of Study Visit in Systolic Blood Pressure	2.52; -0.76	—
SECONDARY Change From Baseline to End of Study Visit in Diastolic Blood Pressure	0.21; 0.82	—
SECONDARY Change From Baseline to End of Study Visit in Pulse Rate	-0.9; 0.8	—
SECONDARY Change From Baseline to End of Study Visit in Body Temperature	-0.053; -0.036	—
SECONDARY Change From Baseline to End of Study Visit in Respiratory Rate	0.0; 0.2	—

Summary

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.

Eligibility Criteria

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00932737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.