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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:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00160290
First received: September 9, 2005
Last updated: April 29, 2008
Last verified: April 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

Drug Information available for: Lactulose
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: David Vilardell, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00160290     History of Changes
Other Study ID Numbers: S105.4.106
Study First Received: September 9, 2005
Last Updated: April 29, 2008
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Solvay Pharmaceuticals:
lactulose
randomised clinical trial
hemorrhoids
anal fissures

Additional relevant MeSH terms:
Fissure in Ano
Hemorrhoids
Anus Diseases
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Vascular Diseases
Cardiovascular Diseases
Lactulose
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013