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The purpose of this study is to assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eductyl suppository | Experimental |
| |
| Placebo suppository | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eductyl suppository | Drug | One suppository every morning during 21 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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
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.
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| Name | Affiliation | Role |
|---|---|---|
| Anne-Laure Tarrerias, Dr | Suresnes Hospital | Principal Investigator |
| Bernard Savarieau, Dr | Nukleus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Foch, Service de Chirurgie Générale et Digestive | Suresnes | 92151 | France |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo suppository |
| Drug |
One suppository every morning during 21 days |
|
| 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 |