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

Tracking Information
First Submitted Date ICMJE	September 9, 2005
First Posted Date ICMJE	September 12, 2005
Last Update Posted Date	May 6, 2008
Study Start Date ICMJE	March 2002
Actual Primary Completion Date	June 2006 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: January 3, 2008)	Quality of life of patients with hard stools and hemorrhoids or anal fissure [ Time Frame: 6 weeks ]
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; (submitted: January 3, 2008)	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 ]
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; Intervention Model: Parallel Assignment; Masking: None (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 Arms	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
Actual Enrollment ICMJE; (submitted: April 29, 2008)	97
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	June 2006
Actual 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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
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	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	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
PRS Account	Solvay Pharmaceuticals
Verification Date	April 2008
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP