NCT00160290TerminatedPhase 4
An Open, Randomized, Parallel Group, Single Center Study to Investigate the Effect of Lactulose Versus Plantago Ovate on the Quality of Life of Patients With Hard Stools and Hemorrhoids or Anal Fissure
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Solvay Pharmaceuticals
- Enrollment
- 97
- Locations
- 8
- Primary Endpoint
- Quality of life of patients with hard stools and hemorrhoids or anal fissure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
B
Active Comparator
Plantago Group
Intervention: Plantago ovata (Drug)
A
Experimental
Lactulose Group
Intervention: Lactulose (Drug)
Outcomes
Primary Outcomes
Quality of life of patients with hard stools and hemorrhoids or anal fissure
Time Frame: 6 weeks
Secondary Outcomes
- 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)
Investigators
Study Sites (8)
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