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

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ClinicalTrials.gov Identifier: NCT00160290
Recruitment Status : Terminated (This trial discontinued on 30 JUN 2006 due to a lack of enrolment)
First Posted : September 12, 2005
Last Update Posted : May 6, 2008
Sponsor:
Information provided by:
Solvay Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hemorrhoids Anal Fissures Drug: Lactulose Drug: Plantago ovata Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
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
Study Start Date : March 2002
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Lactulose
U.S. FDA Resources

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


Outcome Measures
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Primary Outcome Measures :
  1. Quality of life of patients with hard stools and hemorrhoids or anal fissure [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Gastrointestinal Symptoms Rating Scale [ Time Frame: 6 weeks ]
  2. Bristol stool consistency scale [ Time Frame: 6 weeks ]
  3. Number of episodes of rectal bleeding [ Time Frame: 6 weeks ]
  4. Need of rescue medication [ Time Frame: 6 weeks ]

Eligibility Criteria
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: David Vilardell, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00160290     History of Changes
Other Study ID Numbers: S105.4.106
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: May 6, 2008
Last Verified: April 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