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)

Sponsor:

Information provided by:

Solvay Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00160290

First received: September 9, 2005

Last updated: April 29, 2008

Last verified: April 2008

History of Changes

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 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
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 ]

Secondary Outcome Measures:

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 ]


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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


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

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators


Study Director:	Global Clinical Director Solvay	Solvay Pharmaceuticals

More Information


Responsible Party:	David Vilardell, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00160290 History of Changes
Other Study ID Numbers:	S105.4.106
Study First Received:	September 9, 2005
Last Updated:	April 29, 2008

Keywords provided by Solvay Pharmaceuticals:


lactulose randomised clinical trial hemorrhoids anal fissures

Additional relevant MeSH terms:


Hemorrhoids Fissure in Ano Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases	Vascular Diseases Cardiovascular Diseases Anus Diseases Lactulose Gastrointestinal Agents

ClinicalTrials.gov processed this record on September 21, 2017

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