Trial to Evaluate Effect of Lactulose on Hard Stools in Patients With Hemorrhoids or Anal Fissures

Phase 4TerminatedNCT00160290

Solvay Pharmaceuticals97 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hemorrhoids Anal Fissures

Interventions

LactuloseDRUG

15 mL / 12 hours

Plantago ovataDRUG

3,5 g / 12 hours

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (8)

Site 2

Barcelona, Spain

Site 6

Granada, Spain

Site 5

Huesca, Spain

Site 7

Oviedo, Spain

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

Time frame: 6 weeks

Bristol stool consistency scale

Time frame: 6 weeks

Number of episodes of rectal bleeding

Time frame: 6 weeks

Need of rescue medication

Time frame: 6 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.