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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)
Information provided by:
Solvay Pharmaceuticals Identifier:
First received: September 9, 2005
Last updated: April 29, 2008
Last verified: April 2008

September 9, 2005
April 29, 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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00160290 on Archive Site
  • 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 ]
Not Provided
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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.
Not Provided
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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.
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
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