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Trial to Evaluate Effect of Lactulose on Hard Stools in Patients with Hemorrhoids or Anal Fissures - Article


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Hemorrhoids

 



Clinical Trial: Trial to Evaluate Effect of Lactulose on Hard Stools in Patients with Hemorrhoids or Anal Fissures

This study is currently recruiting patients.
Verified by Solvay Pharmaceuticals September 2005

Sponsored by: Solvay Pharmaceuticals
Information provided by: Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00160290

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 fisure.To compare efficacy and quality of life in patients treated either with lactulose or plantago ovata.
Condition Intervention Phase
hemorrhoids; anal fissures
  Drug: Lactulose
 Phase IV

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: An Open, Randomized, Parallel Group, Single Center Study to Investigate the Effect of Lactulose Versus Plantago Ovata on the Quality of Life of Patients with Hard Stools and Hemorrhoids or Anal Fissure.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
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.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00160290

Angels Comas       angels.comas@solvay.com

Spain
      Site 1, Valencia,  Spain; Terminated

      Site 2, Barcelona,  Spain; Recruiting
see Central Contact

      Site 3, Sant Cugat del Vallès (Barcelona),  Spain; Recruiting
see Central Contact

      Site 4, Sabadell, Barcelona,  Spain; Recruiting
see Central Contact

      Site 5, Huesca,  Spain; Recruiting
see Central Contact

      Site 6, Granada,  Spain; Terminated

      Site 7, Oviedo,  Spain; Recruiting
see Central Contact

      Site 8, Santiago de Compostela,  Spain; Recruiting
see Central Contact

Study chairs or principal investigators

Global Clinical Director Solvay,  Study Director,  Solvay Pharmaceuticals   

More Information

Study ID Numbers:  S105.4.106
Last Updated:  September 11, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00160290
Health Authority: Spain: Spanish Agency of Medicines
ClinicalTrials.gov processed this record on 2005-09-13


Source: ClinicalTrials.gov
Cache Date: September 14, 2005

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November 26, 2009


Page Updated: October 15, 2009
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