DyschesiaPhase 4EDUCDYSNCT01243723
Study Assessing the Efficacy of Eductyl® for the Treatment of Patients With Dyschesia
A Phase 4 study testing Eductyl suppository in people with Dyschesia, run by Laboratoires Techni Pharma at 1 site in France.
Trial summary
The purpose of this study is to assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dyschesia
- What is being tested?
- Eductyl suppository
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 306 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2010to Jun 2012
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged from 18 to 75 years old,
- Writing consent to take part in the study,
- Patient with a dyschesia according to Rome III criteria
- An intensity of the inconfort using a VAS (0 (no inconfort) to 100 mm (maximal and no supportable inconfort)) equal or over 40 mm
Who cannot join
- Patient suffering of neurologic affection,
- Rectal diseases including :
- Current anal ou peri-anal pain,
- Current organic injury of colon or rectum,
- Current anal injury,
- Current rectal Prolapse,
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- Current haemorrhoid,
- Colon inflammatory disease (ulcero haemorrhagic recto colitis, Crohn disease…),
- Current ano-recto-colon stenosis (anastomosis, scarring ...)
- Patient undergone pain killers (WHO level II (except dextropropoxyphen) and III) during the last 8 days,
- Patient undergone anti-depressants except if this treatment is regular for at least 15 days and it won't be modified during the study,
- Patient with a constipation treatment except if this treatment is regular for at least 15 days and it won't be modified during the study
- Intolerance to Eductyl® or to one of its components (potassium tartarate acid, sodium bicarbonate, solid hemisynthethic glycerides, soya lecithin, talc)
- Use of Eductyl® during the previous 15 days (over 5 days in the last 15 days),
- Patient already included in clinical trial in the last month,
- Pregnant or breast feeding woman,
- Woman of childbearing potential without contraception,
- Patient unable to read and write.
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Foch, Service de Chirurgie Générale et Digestive
Suresnes, 92151
About this study
Official title: Étude Comparative, randomisée, Double-insu, en Groupes parallèles évaluant l'efficacité d'Eductyl® Versus Placebo Chez Des Patients Souffrant d'Une dyschésie
The purpose of this study is to assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia.
- Conditions
- Dyschesia
- Being tested
- Eductyl suppository, Placebo suppository
- Keywords
- Dyschesia treatment, Inconfort related to dyschesia, Quality of life, Bowel function index
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eductyl suppositoryDrug
One suppository every morning during 21 days
Placebo suppositoryDrug
One suppository every morning during 21 days
| Study group | Role | What they receive |
|---|---|---|
| Eductyl suppository | Experimental | Not described Receives: Drug: Eductyl suppository |
| Placebo suppository | Placebo comparator | Not described Receives: Drug: Placebo suppository |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia on VAS of intensity of inconfort
Measured: Day 0 and day 21
Secondary outcomes (5)
To assess the intensity of inconfort of patients with dyschesia on Likert scale
Measured: Every day from day 0 to day 21
To assess the efficacy of Eductyl versus placebo on dyschesia related quality of life
Measured: Day 0 and day 21
To assess the efficacy of Eductyl versus placebo on bowel function index
Measured: Day 0 and day 21
To assess the efficacy of Eductyl versus placebo on global impression of change
Measured: Day 21
To assess the tolerance of Eductyl versus placebo
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionMar 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyschesiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Techni Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne-Laure Tarrerias, Dr, Principal investigator, Suresnes HospitalBernard Savarieau, Dr, Study director, Nukleus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243723
- Sponsor's protocol ID
- 2010-021919-17
- Acronym
- EDUCDYS
- Status last verified
- Mar 2014
- First submitted
- 17 Nov 2010
- Last updated
- 19 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Étude Comparative, randomisée, Double-insu, en Groupes parallèles évaluant l'efficacité d'Eductyl® Versus Placebo Chez Des Patients Souffrant d'Une dyschésie
- ClinicalTrials.gov ID
- NCT01243723
- Acronym / sponsor ID
- EDUCDYS / 2010-021919-17
- Conditions
- Dyschesia
- Keywords
- Dyschesia treatment, Inconfort related to dyschesia, Quality of life, Bowel function index
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Laboratoires Techni PharmaIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 18 Nov 2010 (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.
The purpose of this study is to assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eductyl suppository | Experimental | Drug: Eductyl suppository |
| Placebo suppository | Placebo comparator | Drug: Placebo suppository |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged from 18 to 75 years old,
- Writing consent to take part in the study,
- Patient with a dyschesia according to Rome III criteria
- An intensity of the inconfort using a VAS (0 (no inconfort) to 100 mm (maximal and no supportable inconfort)) equal or over 40 mm
Key exclusion criteria (18 listed)
- Patient suffering of neurologic affection,
- Rectal diseases including :
- Patient undergone pain killers (WHO level II (except dextropropoxyphen) and III) during the last 8 days,
- Patient undergone anti-depressants except if this treatment is regular for at least 15 days and it won't be modified during the study,
- Patient with a constipation treatment except if this treatment is regular for at least 15 days and it won't be modified during the study
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 |
|---|---|---|
| Eductyl suppositoryOne suppository every morning during 21 days | Drug | Eductyl suppository |
| Placebo suppositoryOne suppository every morning during 21 days | Drug | Placebo suppository |
Primary outcome
To assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia on VAS of intensity of inconfort
Time frame: Day 0 and day 21
5 secondary outcomes
To assess the intensity of inconfort of patients with dyschesia on Likert scale
Time frame: Every day from day 0 to day 21
To assess the efficacy of Eductyl versus placebo on dyschesia related quality of life
Time frame: Day 0 and day 21
To assess the efficacy of Eductyl versus placebo on bowel function index
Time frame: Day 0 and day 21
To assess the efficacy of Eductyl versus placebo on global impression of change
Time frame: Day 21
To assess the tolerance of Eductyl versus placebo
Time frame: Day 21
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 19 Mar 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.
Anne-Laure Tarrerias, Dr principal investigator
Suresnes Hospital
Bernard Savarieau, Dr study director
Nukleus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eductyl suppository in people with Dyschesia, run by Laboratoires Techni Pharma at 1 site in France.
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 4 inclusion and 18 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 19 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
To assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia on VAS of intensity of inconfort (time frame: Day 0 and day 21). 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 19 Mar 2014.