CompletedPhase 2

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

United States197 participantsStarted 2009-06-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 1

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

Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 2

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.

Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 1

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.

Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 2

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.

Percentage of Participants With Response of "no Pain" Based on Numeric Pain Rating Scale (NPRS) in Episode 1

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

Trial details

NCT IDNCT00932737

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-02-08

Results submitted2022-04-06

View on ClinicalTrials.gov More Abdominal Pain trials