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

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. 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
Information provided by:
Solvay Pharmaceuticals

September 9, 2005
September 12, 2005
May 6, 2008
March 2002
June 2006   (Final data collection date for primary outcome measure)
Quality of life of patients with hard stools and hemorrhoids or anal fissure [ Time Frame: 6 weeks ]
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Complete list of historical versions of study NCT00160290 on Archive Site
  • 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 ]
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Trial to Evaluate Effect of Lactulose on Hard Stools in Patients With Hemorrhoids or Anal Fissures
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
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.
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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hemorrhoids
  • Anal Fissures
  • Drug: Lactulose
    15 mL / 12 hours
  • Drug: Plantago ovata
    3,5 g / 12 hours
  • Experimental: A
    Lactulose Group
    Intervention: Drug: Lactulose
  • Active Comparator: B
    Plantago Group
    Intervention: Drug: Plantago ovata
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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June 2006
June 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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David Vilardell, Solvay Pharmaceuticals
Solvay Pharmaceuticals
Not Provided
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
Solvay Pharmaceuticals
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP