NCT00160290

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2002

Longer than P75 for phase_4

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

May 6, 2008

Status Verified

April 1, 2008

Enrollment Period

4.3 years

First QC Date

September 9, 2005

Last Update Submit

April 29, 2008

Conditions

HemorrhoidsAnal Fissures

Keywords

lactuloserandomised clinical trialhemorrhoidsanal fissures

Outcome Measures

Primary Outcomes (1)

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

    6 weeks

Secondary Outcomes (4)

  • 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

Study Arms (2)

A

EXPERIMENTAL

Lactulose Group

Drug: Lactulose

B

ACTIVE COMPARATOR

Plantago Group

Drug: Plantago ovata

Interventions

LactuloseDRUG

15 mL / 12 hours

A
Plantago ovataDRUG

3,5 g / 12 hours

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suffering from symptomatic hemorrhoids, or symptomatic anal fissure.

You may not qualify if:

  • Patients suffering from malignant tumor in the intestine or the anal-rectal region, irritable colon, intestine inflammatory disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Site 2

Barcelona, Spain

Location

Site 6

Granada, Spain

Location

Site 5

Huesca, Spain

Location

Site 7

Oviedo, Spain

Location

Site 4

Sabadell (Barcelona), Spain

Location

Site 3

Sant Cugat Del Vallès (Barcelona), Spain

Location

Site 8

Santiago de Compostela, Spain

Location

Site 1

Valencia, Spain

Location

MeSH Terms

Conditions

HemorrhoidsFissure in Ano

Interventions

LactulosePsyllium

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular DiseasesAnus Diseases

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugarsPlant ExtractsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Global Clinical Director Solvay

    Solvay Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 12, 2005

Study Start

March 1, 2002

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

May 6, 2008

Record last verified: 2008-04

Locations

ES(8)