CompletedPhase 2

Study to Evaluate Efficacy and Safety of Oral Doses of Hyoscine Butylbromide for the Treatment of Occasional Abdominal Pain, Cramping, and Discomfort

527 participantsStarted 2006-04

Plain-language summary

Study to determine whether hyoscine butylbromide can provide adequate symptomatic relief of a single episode - defined as lasting not longer than 1 day - and multiple episodes of abdominal pain or discomfort associated with cramping when used as needed

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

✓. Adult males and females 18 years of age and older
✓. Have at least a 3-month self-reported history of recurrent episodic symptoms, usually lasting for 1 hour or more, of self-described abdominal pain or discomfort associated with cramping, which they routinely either have not treated or treated using Over-the-counter (OTC) medications, in which subjects suffered these symptoms at a frequency of at least twice monthly to several times weekly, but not on a daily basis. The episodes of abdominal pain or discomfort may have been associated with other symptoms of GI dysfunction, such as diarrhea, constipation, and bloating
✓. Symptoms typically have a moderate or greater severity (moderate, severe, very severe) and are sufficiently bothersome to require treatment or intervention
✓. Symptoms are not associated with abdominal tenderness, swelling, fever, weight loss, or passage of blood per rectum. The onset of symptoms may or may not have been associated with ingestion of food or beverages
✓. The episodes of abdominal pain or discomfort may have been associated with other symptoms of GI dysfunction, such as diarrhea, cramping, constipation, and bloating
✓. Subjects are required to be able to comprehend and participate in the activities required for participation in the trial, to have the ability to attend required site visits, and to be available and have the facility to participate in a daily telephone call or computer entry (using a touch-tone phone or computer IVRS entry), which served as the mechanism for diary entry, during the 6-week course of the study. Subjects were required to successfully complete an Interactive voice response system (IVRS) training session prior to entry into the study
✓. All subjects completed and signed an informed consent form

Exclusion criteria

✕. Subjects who reported having these symptoms for the first time, particularly if they were 50 years or older, as this may have been a sign of a more serious organic disease
✕. Subjects with a known hypersensitivity or allergy to hyoscine butylbromide or any of the inactive ingredients
✕. Subjects who are currently under a physician's care for abdominal symptoms and/or not using medication or using prescription or OTC medications prescribed by a physician to treat symptoms of abdominal pain, cramping and discomfort or taking prescription medication(s) for the treatment of Irritable bowel syndrome (IBS) (Bentyl® or other antispasmodics, Zelnorm® \[tegaserod\], Lotronex® \[alosetron\], prokinetic agents). Current physician's care was defined as the subject presently following clinician advice regarding treatment and management of the abdominal pain or discomfort associated with the cramping symptom
✕. Subjects who are having symptoms of abdominal swelling, fever associated with symptoms of abdominal pain or discomfort associated with cramping, and/or experiencing passage of blood per rectum associated with symptoms of abdominal pain or discomfort associated with cramping, or who have any evidence of abdominal tenderness (or any other evidence of an acute abdomen), abdominal masses, organomegaly or any other abnormality on abdominal examination
✕. Subjects with a history of colon or other GI cancer or malignancy, inflammatory bowel disease, or Crohn's disease
✕. Subjects with chronic constipation
✕. Subjects with myasthenia gravis or megacolon
✕. Subjects who have undergone abdominal surgery within the past 2 years, having GI surgery resulting in removal of all or part of the colon, small intestine, or stomach, or having a history of GI by-pass surgery for weight reduction

What they're measuring

Response rate in treating the first episode of abdominal pain or discomfort associated with cramping

Timeframe: within 24 hours after starting treatment

Trial details

NCT IDNCT02242292

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-01

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