Study Assessing the Efficacy of Eductyl® for the Treatment of Patients With Dyschesia

NCT01243723 | Completed Phase 4 DMC

• 1 other identifier: 2010-021919-17
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dyschesia

Keywords

Dyschesia treatment; Inconfort related to dyschesia; Quality of life; Bowel function index

Outcome Measures

Primary Outcomes (1)

• To assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia on VAS of intensity of inconfort

  Day 0 and day 21

Secondary Outcomes (5)

• To assess the intensity of inconfort of patients with dyschesia on Likert scale

  Every day from day 0 to day 21

• To assess the efficacy of Eductyl versus placebo on dyschesia related quality of life

  Day 0 and day 21

• To assess the efficacy of Eductyl versus placebo on bowel function index

  Day 0 and day 21

• To assess the efficacy of Eductyl versus placebo on global impression of change

  Day 21

• To assess the tolerance of Eductyl versus placebo

  Day 21

Study Arms (2)

Eductyl suppository

EXPERIMENTAL

Drug: Eductyl suppository

Placebo suppository

PLACEBO COMPARATOR

Drug: Placebo suppository

Interventions

Eductyl suppository DRUG

One suppository every morning during 21 days

Eductyl suppository

Placebo suppository DRUG

One suppository every morning during 21 days

Placebo suppository

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,
• 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,

Sponsors & Collaborators

• Laboratoires Techni Pharma: lead

Study Sites (1)

Hôpital Foch, Service de Chirurgie Générale et Digestive

Suresnes, 92151, France

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne-Laure Tarrerias, Dr

  Suresnes Hospital

  PRINCIPAL INVESTIGATOR

• Bernard Savarieau, Dr

  Nukleus

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 18, 2010
• Study Start: November 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 19, 2014

Record last verified: 2014-03

Locations

FR (1)