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

Boehringer Ingelheim

Status and phase

Completed

Phase 2

Conditions

Colic

Treatments

Drug: Hyoscine butylbromide

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02242292

202.832

Details and patient eligibility

About

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

Enrollment

527 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
Prior history of gallbladder removal, appendectomy, and/or surgery for peptic ulcer disease or gastroesophageal reflux disease (GERD), was not exclusionary.
Subjects whose major symptoms were retrosternal burning, acid reflux, acid regurgitation, or heartburn are excluded
Subjects using prescription anticholinergic medications or medications for the treatment of myasthenia gravis, glaucoma, or ocular hypertension are excluded
Subjects who were currently participating in other trials or who participated in a clinical trial within the prior 30 days are excluded
Women who reported being pregnant, are nursing, or who are of child-bearing potential and not using an adequate method of birth control (medication, device, abstinence, sterilization for either partner) for 30 days before enrollment and did not agree to continue using an adequate method of birth control for 30 days after completion of the trial are excluded
Any women of childbearing potential who have a positive serum pregnancy test are excluded
Post-menopausal women who have been post-menopausal for a duration of less than 2 years and did not have a hysterectomy or tubal ligation procedure are excluded
Subjects who have tachyarrhythmia (defined as any disturbance of the heart's rhythm, regular or irregular, resulting in a rate over 100 beats per minute) during a physical examination are excluded
Subjects who have been previously diagnosed with benign prostatic hyperplasia (BPH) or subjects who experienced urinary retention are excluded
Subjects with clinically significant cardiovascular disease in the opinion of the investigator (including hypotension, hypertension, severe coronary artery disease, congestive heart failure, angina pectoris) are excluded