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Efficacy of Eductyl® Versus Placebo for Treatment of Dyschesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laboratoires Techni Pharma
ClinicalTrials.gov Identifier:
NCT00910832
First received: May 29, 2009
Last updated: March 18, 2014
Last verified: March 2014

May 29, 2009
March 18, 2014
May 2009
December 2011   (final data collection date for primary outcome measure)
To assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia treated by rectal rehabilitation on VAS of intensity of symptoms [ Time Frame: Day -7, 0, 3, 7, 10, 14, 17, and 21 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00910832 on ClinicalTrials.gov Archive Site
To assess the efficacy on change symptoms and safety of Eductyl versus placebo for treatment of patients with dyschesia treated by rectal rehabilitation [ Time Frame: Day 0 and 21 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dyschesia
  • Drug: Eductyl suppository
    one suppository every morning during 21 days
  • Drug: Placebo suppository
    placebo suppository every morning during 21 days
  • Experimental: Eductyl suppository
    Intervention: Drug: Eductyl suppository
  • Placebo Comparator: Placebo suppository
    Intervention: Drug: Placebo suppository
Cotelle O, Cargill G, Marty MM, Bueno L, Cappelletti MC, Colangeli-Hagège H, Savarieau B, Ducrotté P. A concomitant treatment by CO2-releasing suppositories improves the results of anorectal biofeedback training in patients with dyschezia: results of a randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2014 Jun;57(6):781-9. doi: 10.1097/DCR.0000000000000098.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
306
June 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00910832
07-EDU-01, EudraCT N° : 2007-0003658-27
No
Laboratoires Techni Pharma
Laboratoires Techni Pharma
Not Provided
Principal Investigator: Odile Cotelle, Dr Diaconesses hospital
Laboratoires Techni Pharma
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP