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

NCT02242292 | Completed Phase 2

• 1 other identifier: 202.832
• Study Type: interventional
• Target: 527
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Colic

Outcome Measures

Primary Outcomes (1)

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

  (Response was defined as achieving adequate relief of symptoms, as measured on a subject's diary using a dichotomized response to the question)

  within 24 hours after starting treatment

Secondary Outcomes (17)

• Response rate to trial medication

  up to day 41

• Assessment of Average symptom relief rated on 4-point scale

  up to day 41

• Time to onset of any effect after the first tablet taken assessed on 5-point scale

  within 24 hours after starting treatment

• Time to onset of any effect assessed on 5-point scale

  up to day 41

• Time to obtain adequate relief after the first tablet taken assessed on 5-point scale

  within 24 hours after starting treatment

Study Arms (2)

Hyoscine butylbromide

EXPERIMENTAL

5 tablets taken in a 24-hour period/each episode: * for up to 7 episodes, or * over a period of up to 6 weeks

Drug: Hyoscine butylbromide

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Hyoscine butylbromide DRUG

Hyoscine butylbromide

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Related Links

• Related Info

MeSH Terms

Conditions

Colic

Interventions

Butylscopolammonium Bromide

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: September 17, 2014
• Study Start: April 1, 2006
• Primary Completion: January 1, 2007
• Last Updated: December 28, 2017

Record last verified: 2017-12