- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02211976
Efficacy and Tolerability of Bisacodyl Sugar Coated Tablets, Simeticone Chewing Tablets and Their Combination in Constipation and Bloatedness
August 7, 2014 updated by: Boehringer Ingelheim
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
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bisacodyl
|
|
Experimental: Simeticone
|
|
Experimental: Bisacodyl and simeticone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in bloatedness score on a 4-point-scale
Time Frame: baseline, 1 hour after drug administration
|
baseline, 1 hour after drug administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in bloatedness score on a 4-point-scale
Time Frame: baseline, 2 hours, 3 hours, at time of defecation
|
baseline, 2 hours, 3 hours, at time of defecation
|
Time to defecation
Time Frame: up to 7 days
|
up to 7 days
|
Number of withdrawals due to inadequate efficiency
Time Frame: up to 7 days
|
up to 7 days
|
Patient's global assessment of efficacy on a 4-point-scale
Time Frame: up to 7 days
|
up to 7 days
|
Number of patients with adverse events
Time Frame: up to 7 days
|
up to 7 days
|
Number of patients with abnormal laboratory findings
Time Frame: up to 7 days
|
up to 7 days
|
Number of withdrawals due to safety reasons
Time Frame: up to 7 days
|
up to 7 days
|
Patient's assessment of overall tolerability on a 4-point-scale
Time Frame: up to 7 days
|
up to 7 days
|
Investigator's assessment of overall tolerability on a 4-point-scale
Time Frame: up to 7 days
|
up to 7 days
|
Number of patients with clinically significant changes in vital signs
Time Frame: up to 7 days
|
up to 7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2003
Primary Completion (Actual)
November 1, 2003
Study Registration Dates
First Submitted
August 7, 2014
First Submitted That Met QC Criteria
August 7, 2014
First Posted (Estimate)
August 8, 2014
Study Record Updates
Last Update Posted (Estimate)
August 8, 2014
Last Update Submitted That Met QC Criteria
August 7, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 122.52
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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