Efficacy and Tolerability of Bisacodyl Sugar Coated Tablets, Simeticone Chewing Tablets and Their Combination in Constipation and Bloatedness

Constipation Clinical Trial

Official title:

Comparative Efficacy and Tolerability of Bisacodyl Sugar Coated Tablets, Simeticone Chewing Tablets and the Combination of Both in the Treatment of Constipation and Bloatedness: an Open, Randomised, Parallel Group Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02211976
• Other study ID #: 122.52
• Status: Completed
• Phase: Phase 3
• First received: August 7, 2014
• Last updated: August 7, 2014
• Start date: October 2003

Study information

• Verified date: August 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Pilot study to evaluate the efficacy and tolerability of the combined treatment of bisacodyl and simeticone compared with the efficacy and tolerability of the single products in patients suffering from constipation and bloatedness

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of constipation, defined as acute and habitual constipation; concomitantly patient must have complaint of bloated feeling

• Patient was to be 18 years of age or older

• Females who were of child bearing potential must have a negative pre-study urine pregnancy test and must be using oral or barrier contraceptive methods throughout the study. If oral contraceptives were used, the patient must be using them for at least 3 months prior to enrolment into the study

• Patient must be willing to maintain a diary throughout the study

• Patient must be otherwise in good health

• Patient must sign an informed consent form which has been prepared in accordance with the Declaration of Helsinki

Exclusion Criteria:

• Patient had drug-induced constipation resulting from drugs such as opioids, dopaminergics, antacids, anticholinergics or diuretics

• Patient had a history of organic diseases of the colon such as tumors, stricture, and acute or chronic inflammatory diseases, ileus, acute surgical abdominal conditions such as acute appendicitis, or organic diseases of the rectum and anus such as fissures, fistulas, perianal abscesses, and eczema of the perianal skin

• Patient exhibited evidence of active gastrointestinal disease

• Patient was diagnosed as having intestinal obstruction, had any undiagnosed abdominal symptoms, or was in severe dehydration

• Patient had a history of major gastrointestinal surgery

• Patient had a history of hypersensitivity to substances of the triarylmethane class

• Patient had a history of hypersensitivity to substances of the class of parahydroxybenzoic esters (para group allergy)

• Patient had a history of drug or alcohol abuse

• Patient had received bisacodyl for the treatment of another indication or in a previous study within the last 7 days before enrolment.

• Patient had ingested any drug in the past week before enrolment that in the opinion of the investigator would have an effect on gastrointestinal motility (e.g. anti-cholinergic medications, opioids, smooth muscle relaxants or antacids)

• Patient required the use of a drug, other than study drug, or dietary supplement to relieve the symptoms of constipation at any time during the baseline or treatment phases of this study

• Patient was currently taking any form of tetracycline antibiotics

• Patient was a nursing mother

• Patient had received any investigational drug within the previous 4 weeks prior to enrolment

• Patient had any condition that would interfere with the completion of this study, or that would decrease the likelihood of obtaining valid results

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• Bisacodyl

• Simeticone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bloatedness score on a 4-point-scale		baseline, 1 hour after drug administration	No
Secondary	Change in bloatedness score on a 4-point-scale		baseline, 2 hours, 3 hours, at time of defecation	No
Secondary	Time to defecation		up to 7 days	No
Secondary	Number of withdrawals due to inadequate efficiency		up to 7 days	No
Secondary	Patient's global assessment of efficacy on a 4-point-scale		up to 7 days	No
Secondary	Number of patients with adverse events		up to 7 days	No
Secondary	Number of patients with abnormal laboratory findings		up to 7 days	No
Secondary	Number of withdrawals due to safety reasons		up to 7 days	No
Secondary	Patient's assessment of overall tolerability on a 4-point-scale		up to 7 days	No
Secondary	Investigator's assessment of overall tolerability on a 4-point-scale		up to 7 days	No
Secondary	Number of patients with clinically significant changes in vital signs		up to 7 days	No

External Links

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