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

Primary Purpose

Hemorrhoids, Anal Fissures

Status
Terminated
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Lactulose
Plantago ovata
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhoids focused on measuring lactulose, randomised clinical trial, hemorrhoids, anal fissures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site 2
  • Site 6
  • Site 5
  • Site 7
  • Site 4
  • Site 3
  • Site 8
  • Site 1

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Lactulose Group

Plantago Group

Outcomes

Primary Outcome Measures

Quality of life of patients with hard stools and hemorrhoids or anal fissure

Secondary Outcome Measures

Gastrointestinal Symptoms Rating Scale
Bristol stool consistency scale
Number of episodes of rectal bleeding
Need of rescue medication

Full Information

First Posted
September 9, 2005
Last Updated
April 29, 2008
Sponsor
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00160290
Brief Title
Trial to Evaluate Effect of Lactulose on Hard Stools in Patients With Hemorrhoids or Anal Fissures
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Terminated
Why Stopped
This trial discontinued on 30 JUN 2006 due to a lack of enrolment
Study Start Date
March 2002 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoids, Anal Fissures
Keywords
lactulose, randomised clinical trial, hemorrhoids, anal fissures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Lactulose Group
Arm Title
B
Arm Type
Active Comparator
Arm Description
Plantago Group
Intervention Type
Drug
Intervention Name(s)
Lactulose
Intervention Description
15 mL / 12 hours
Intervention Type
Drug
Intervention Name(s)
Plantago ovata
Intervention Description
3,5 g / 12 hours
Primary Outcome Measure Information:
Title
Quality of life of patients with hard stools and hemorrhoids or anal fissure
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Gastrointestinal Symptoms Rating Scale
Time Frame
6 weeks
Title
Bristol stool consistency scale
Time Frame
6 weeks
Title
Number of episodes of rectal bleeding
Time Frame
6 weeks
Title
Need of rescue medication
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 2
City
Barcelona
Country
Spain
Facility Name
Site 6
City
Granada
Country
Spain
Facility Name
Site 5
City
Huesca
Country
Spain
Facility Name
Site 7
City
Oviedo
Country
Spain
Facility Name
Site 4
City
Sabadell (Barcelona)
Country
Spain
Facility Name
Site 3
City
Sant Cugat del Vallès (Barcelona)
Country
Spain
Facility Name
Site 8
City
Santiago de Compostela
Country
Spain
Facility Name
Site 1
City
Valencia
Country
Spain

12. IPD Sharing Statement

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

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