Trial to Evaluate Effect of Lactulose on Hard Stools in Patients With Hemorrhoids or Anal Fissures
- Registration Number
- NCT00160290
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief Summary
To demonstrate that lactulose acts as a stool softener, relieving the pain at defecation, improving the number of defecations and regulating the colonic transit time in patients suffering of hemorrhoids or anal fissure. To compare efficacy and quality of life in patients treated either with lactulose or plantago ovate.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 97
Inclusion Criteria
- Patients suffering from symptomatic hemorrhoids, or symptomatic anal fissure.
Exclusion Criteria
- Patients suffering from malignant tumor in the intestine or the anal-rectal region, irritable colon, intestine inflammatory disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Lactulose Lactulose Group B Plantago ovata Plantago Group
- Primary Outcome Measures
Name Time Method Quality of life of patients with hard stools and hemorrhoids or anal fissure 6 weeks
- Secondary Outcome Measures
Name Time Method Gastrointestinal Symptoms Rating Scale 6 weeks Bristol stool consistency scale 6 weeks Number of episodes of rectal bleeding 6 weeks Need of rescue medication 6 weeks
Trial Locations
- Locations (8)
Site 2
🇪🇸Barcelona, Spain
Site 6
🇪🇸Granada, Spain
Site 5
🇪🇸Huesca, Spain
Site 7
🇪🇸Oviedo, Spain
Site 4
🇪🇸Sabadell (Barcelona), Spain
Site 3
🇪🇸Sant Cugat del Vallès (Barcelona), Spain
Site 8
🇪🇸Santiago de Compostela, Spain
Site 1
🇪🇸Valencia, Spain
Site 2🇪🇸Barcelona, Spain