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

NCT ID: NCT00160290

Last Updated: 2008-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2006-06-30

Brief Summary

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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

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Conditions

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Hemorrhoids Anal Fissures

Keywords

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lactulose randomised clinical trial hemorrhoids anal fissures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Lactulose Group

Group Type EXPERIMENTAL

Lactulose

Intervention Type DRUG

15 mL / 12 hours

B

Plantago Group

Group Type ACTIVE_COMPARATOR

Plantago ovata

Intervention Type DRUG

3,5 g / 12 hours

Interventions

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Lactulose

15 mL / 12 hours

Intervention Type DRUG

Plantago ovata

3,5 g / 12 hours

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Solvay Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Solvay Pharmaceuticals

Principal Investigators

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Global Clinical Director Solvay

Role: STUDY_DIRECTOR

Solvay Pharmaceuticals

Locations

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Site 2

Barcelona, , Spain

Site Status

Site 6

Granada, , Spain

Site Status

Site 5

Huesca, , Spain

Site Status

Site 7

Oviedo, , Spain

Site Status

Site 4

Sabadell (Barcelona), , Spain

Site Status

Site 3

Sant Cugat Del Vallès (Barcelona), , Spain

Site Status

Site 8

Santiago de Compostela, , Spain

Site Status

Site 1

Valencia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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S105.4.106

Identifier Type: -

Identifier Source: org_study_id