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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
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00160290

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
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

Responsible Party: David Vilardell, Solvay Pharmaceuticals Identifier: NCT00160290     History of Changes
Other Study ID Numbers: S105.4.106
Study First Received: September 9, 2005
Last Updated: April 29, 2008

Keywords provided by Solvay Pharmaceuticals:
randomised clinical trial
anal fissures

Additional relevant MeSH terms:
Fissure in Ano
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Anus Diseases
Gastrointestinal Agents processed this record on September 18, 2017