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Efficacy of Eductyl® Versus Placebo for Treatment of Dyschesia

Comparative, Randomized, Double-blind Study of the Efficacy of Eductyl® Versus Placebo for Treatment of Patients With Dyschesia Treated by Rectal Rehabilitation

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00910832
Acronym
Eductyl
Enrollment
306
Registered
2009-06-01
Start date
2009-05-31
Completion date
2012-06-30
Last updated
2014-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyschesia

Keywords

Dyschesia treatment, Rehabilitation, Dyschesia

Brief summary

The purpose of this study is to assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia treated by rectal rehabilitation.

Interventions

one suppository every morning during 21 days

placebo suppository every morning during 21 days

Sponsors

Laboratoires Techni Pharma
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Male or female over 18 years * Patients with dyschesia * Prescription of rehabilitation for dyschesia

Exclusion criteria

* Rectal diseases * Pain killers * Pregnant women * Breast feeding patients * Non-compliant patients

Design outcomes

Primary

MeasureTime frame
To assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia treated by rectal rehabilitation on VAS of intensity of symptomsDay -7, 0, 3, 7, 10, 14, 17, and 21

Secondary

MeasureTime frame
To assess the efficacy on change symptoms and safety of Eductyl versus placebo for treatment of patients with dyschesia treated by rectal rehabilitationDay 0 and 21

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026