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

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

April 29, 2008

Start Date ^ICMJE

March 2002

Primary Completion Date

June 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Quality of life of patients with hard stools and hemorrhoids or anal fissure [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00160290 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hemorrhoids
Anal Fissures

Intervention ^ICMJE

Drug: Lactulose
15 mL / 12 hours
Drug: Plantago ovata
3,5 g / 12 hours

Study Arm (s)

Experimental: A
Lactulose Group

Intervention: Drug: Lactulose
Active Comparator: B
Plantago Group

Intervention: Drug: Plantago ovata

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

June 2006

Primary Completion Date

June 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Spain

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00160290

Other Study ID Numbers ^ICMJE

S105.4.106

Has Data Monitoring Committee

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

David Vilardell, Solvay Pharmaceuticals

Study Sponsor ^ICMJE

Solvay Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

Information Provided By

Solvay Pharmaceuticals

Verification Date

April 2008

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

To Top