Study to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Tablets for the Treatment of Occasional or Recurrent Episodes of Gastric or Intestinal Spasm-like Pain or Discomfort

NCT02242305 | Completed Phase 3 Results

• 1 other identifier: 202.838
• Study Type: interventional
• Target: 302
• Locations: 0 countries
• Sites: N/A

Brief Summary

In contrast with Hyoscine Butylbromide Capsule 10mg, Study is to evaluate the efficacy and safety of Hyoscine Butylbromide tablets 10 mg (20mg, 3 times daily, orally) over a period of 3 days for the treatment of occasional or recurrent episodes of self-reported gastric or intestinal spasm-like pain or discomfort

Conditions

Abdominal Pain

Outcome Measures

Primary Outcomes (1)

• Change of the Mean Pain Intensity Score Measured on a Visual Analogue Scale (VAS) Within 3 Days (and Within 1 Day) - ANCOVA

  The endpoint presents change of the mean Visual Analogue Scale (VAS) of pain intensity score, recorded daily by the patient in the evening in his/her patient diary describing pain intensity during the previous 24 hours, from the baseline pain intensity. The baseline pain intensity was the pain intensity of first episode on Day 1 after randomization before taking study medication. The mean VAS pain intensity score was calculated for the 3-day treatment period. A VAS for describing the pain intensity was used (VAS: maximum score of 10 cm, the score from 0 - 10 cm reaching from "no pain" to "the most severe pain imaginable").

  3 days (1 day)

Secondary Outcomes (6)

• Change of the Pain Frequency Assessed on 4-stage Verbal Rating Scale (VRS)

  Up to 3 days.

• Global Assessment of Efficacy by Patient on 4-point Scale

  Post 3 days of treatment.

• Number of Patients With Adverse Events

  Up to 3 days.

• Global Assessment of Tolerability by Investigator on a 4-point Scale

  Day 3.

• Number of Subjects With Clinical Relevant Abnormalities for Laboratory, Vital Signs, ElectroCardioGram (ECG) and Physical Examination

  Up to 3 days.

Study Arms (2)

Hyoscine Butylbromide - Tablet

EXPERIMENTAL

Drug: Hyoscine Butylbromide - Tablet; Drug: Placebo

Hyoscine Butylbromide - Capsule

ACTIVE COMPARATOR

Drug: Hyoscine Butylbromide - Capsule; Drug: Placebo

Interventions

Hyoscine Butylbromide - Tablet DRUG

Hyoscine Butylbromide - Tablet

Hyoscine Butylbromide - Capsule DRUG

Hyoscine Butylbromide - Capsule

Placebo DRUG

Hyoscine Butylbromide - Capsule; Hyoscine Butylbromide - Tablet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written Informed Consent given by the patient
• Male and female patients aging from 18 to 70
• Subjects with occasional or recurrent episodes of gastric or intestinal spasm-like pain, or discomfort, such as occur e.g. in irritable bowel syndrome, which has been present for at least 3 months
• The pain intensity score upon screening is at least 4 cm in VAS score

You may not qualify if:

• Patients with the following concomitant disease were not eligible for enrolment
• Painful gastric or intestinal spasm of organic origin such as Crohn's disease, ulcerative colitis, lactose intolerance, gastritis, ulcer. Exception: diverticulitis and mild gastritis if dominant symptom was cramp pain, but ineligible if heartburn or reflux were dominant symptoms
• Pain related with malignancy
• Patients with other severe pain states of organic origin
• Mechanical stenosis of the gastrointestinal tract, megacolon
• Urinary retention associated with mechanical stenosis of urinary tract
• Narrow-angled glaucoma
• Tachyarrhythmia
• Myasthenia gravis
• Meulengracht-Gilbert syndrome
• Known depression or known mental illness, anxiety disturbance
• Frequent vomiting that might have prevented adequate absorption of the active ingredient after the film-coated tablet was taken
• Patients taking the following concomitant medication are not eligible for enrolment
• Analgesics
• Spasmolytics

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Abdominal Pain

Interventions

Butylscopolammonium Bromide

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

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

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• 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: November 1, 2008
• Primary Completion: July 20, 2009
• Study Completion: July 20, 2009
• Last Updated: July 27, 2017
• Results First Posted: July 27, 2017

Record last verified: 2017-07