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

NCT02211976 | Completed Phase 3

• 1 other identifier: 122.52
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• Change in bloatedness score on a 4-point-scale

  baseline, 1 hour after drug administration

Secondary Outcomes (10)

• Change in bloatedness score on a 4-point-scale

  baseline, 2 hours, 3 hours, at time of defecation

• Time to defecation

  up to 7 days

• Number of withdrawals due to inadequate efficiency

  up to 7 days

• Patient's global assessment of efficacy on a 4-point-scale

  up to 7 days

• Number of patients with adverse events

  up to 7 days

Study Arms (3)

Bisacodyl

EXPERIMENTAL

Drug: Bisacodyl

Simeticone

EXPERIMENTAL

Drug: Simeticone

Bisacodyl and simeticone

EXPERIMENTAL

Drug: Bisacodyl; Drug: Simeticone

Interventions

Bisacodyl DRUG

Bisacodyl; Bisacodyl and simeticone

Simeticone DRUG

Bisacodyl and simeticone; Simeticone

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Constipation

Interventions

Bisacodyl; Simethicone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Dimethylpolysiloxanes; Silicones; Siloxanes; Organosilicon Compounds; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 8, 2014
• Study Start: October 1, 2003
• Primary Completion: November 1, 2003
• Last Updated: August 8, 2014

Record last verified: 2014-08