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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:
ClinicalTrials.gov Identifier:
NCT00160290
First Posted: September 12, 2005
Last Update Posted: May 6, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Solvay Pharmaceuticals
  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:


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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

Responsible Party: David Vilardell, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00160290     History of Changes
Other Study ID Numbers: S105.4.106
First Submitted: September 9, 2005
First Posted: September 12, 2005
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