ConstipationPhase 3NCT02211976
Efficacy and Tolerability of Bisacodyl Sugar Coated Tablets, Simeticone Chewing Tablets and Their Combination in Constipation and Bloatedness
A Phase 3 study testing Bisacodyl and Simeticone in people with Constipation, run by Boehringer Ingelheim.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation
- What is being tested?
- Bisacodyl and Simeticone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2003to Nov 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
About this study
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
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
- Being tested
- Bisacodyl, Simeticone
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BisacodylDrug
SimeticoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Bisacodyl | Experimental | Not described Receives: Drug: Bisacodyl |
| Simeticone | Experimental | Not described Receives: Drug: Simeticone |
| Bisacodyl and simeticone | Experimental | Not described Receives: Drug: Bisacodyl; Drug: Simeticone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bloatedness score on a 4-point-scale
Measured: baseline, 1 hour after drug administration
Secondary outcomes (10)
Change in bloatedness score on a 4-point-scale
Measured: baseline, 2 hours, 3 hours, at time of defecation
Time to defecation
Measured: up to 7 days
Number of withdrawals due to inadequate efficiency
Measured: up to 7 days
Patient's global assessment of efficacy on a 4-point-scale
Measured: up to 7 days
Number of patients with adverse events
Measured: up to 7 days
Number of patients with abnormal laboratory findings
Measured: up to 7 days
Number of withdrawals due to safety reasons
Measured: up to 7 days
Patient's assessment of overall tolerability on a 4-point-scale
Measured: up to 7 days
Investigator's assessment of overall tolerability on a 4-point-scale
Measured: up to 7 days
Number of patients with clinically significant changes in vital signs
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startOct 2003
- Primary completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211976
- Sponsor's protocol ID
- 122.52
- Status last verified
- Aug 2014
- First submitted
- 7 Aug 2014
- Last updated
- 8 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02211976
- Acronym / sponsor ID
- 122.52
- Conditions
- Constipation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Nov 2003 (actual)
- First posted
- 8 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bisacodyl | Experimental | Drug: Bisacodyl |
| Simeticone | Experimental | Drug: Simeticone |
| Bisacodyl and simeticone | Experimental | Drug: Bisacodyl, Drug: Simeticone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bisacodyl | Drug | Bisacodyl, Bisacodyl and simeticone |
| Simeticone | Drug | Bisacodyl and simeticone, Simeticone |
Primary outcome
Change in bloatedness score on a 4-point-scale
Time frame: baseline, 1 hour after drug administration
10 secondary outcomes
Change in bloatedness score on a 4-point-scale
Time frame: baseline, 2 hours, 3 hours, at time of defecation
Time to defecation
Time frame: up to 7 days
Number of withdrawals due to inadequate efficiency
Time frame: up to 7 days
Patient's global assessment of efficacy on a 4-point-scale
Time frame: up to 7 days
Number of patients with adverse events
Time frame: up to 7 days
Number of patients with abnormal laboratory findings
Time frame: up to 7 days
Number of withdrawals due to safety reasons
Time frame: up to 7 days
Patient's assessment of overall tolerability on a 4-point-scale
Time frame: up to 7 days
Investigator's assessment of overall tolerability on a 4-point-scale
Time frame: up to 7 days
Number of patients with clinically significant changes in vital signs
Time frame: up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bisacodyl and Simeticone in people with Constipation, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bloatedness score on a 4-point-scale (time frame: baseline, 1 hour after drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2014.