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

This study has been terminated.

( This trial discontinued on 30 JUN 2006 due to a lack of enrolment )

First Received: September 9, 2005 Last Updated: April 29, 2008 History of Changes

Sponsor:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00160290

Purpose

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.

Condition	Intervention	Phase
Hemorrhoids Anal Fissures	Drug: Lactulose Drug: Plantago ovata	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement Hemorrhoids

Drug Information available for: Lactulose

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Quality of life of patients with hard stools and hemorrhoids or anal fissure [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Gastrointestinal Symptoms Rating Scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Bristol stool consistency scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Number of episodes of rectal bleeding [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Need of rescue medication [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	97
Study Start Date:	March 2002
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Lactulose Group	Drug: Lactulose 15 mL / 12 hours
B: Active Comparator Plantago Group	Drug: Plantago ovata 3,5 g / 12 hours

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160290

Locations

Spain
Site 1
Valencia, Spain
Site 2
Barcelona, Spain
Site 3
Sant Cugat del Vallès (Barcelona), Spain
Site 4
Sabadell (Barcelona), Spain
Site 8
Santiago de Compostela, Spain
Site 6
Granada, Spain
Site 7
Oviedo, Spain
Site 5
Huesca, Spain

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Responsible Party:	Solvay Pharmaceuticals ( David Vilardell )
Study ID Numbers:	S105.4.106
Study First Received:	September 9, 2005
Last Updated:	April 29, 2008
ClinicalTrials.gov Identifier:	NCT00160290 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Solvay Pharmaceuticals:

lactulose
randomised clinical trial
hemorrhoids
anal fissures

Additional relevant MeSH terms:

Gastrointestinal Diseases
Vascular Diseases
Gastrointestinal Agents
Intestinal Diseases
Rectal Diseases
Pharmacologic Actions
Fissure in Ano

Digestive System Diseases
Therapeutic Uses
Hemorrhoids
Cardiovascular Diseases
Anus Diseases
Lactulose

ClinicalTrials.gov processed this record on November 27, 2009