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

• ClinicalTrials.gov Identifier: NCT00160290
• Recruitment Status: Terminated
• First Posted: September 12, 2005
• Last Update Posted: May 6, 2008
• Sponsor: Solvay Pharmaceuticals
• Information provided by: Solvay Pharmaceuticals

Tracking Information

• First Submitted Date: September 9, 2005
• First Posted Date: September 12, 2005
• Last Update Posted Date: May 6, 2008
• Study Start Date: March 2002
• Actual Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Not Provided

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Trial to Evaluate Effect of Lactulose on Hard Stools in Patients With Hemorrhoids or Anal Fissures
• 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
• 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Hemorrhoids
• Anal Fissures

Intervention

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 29, 2008): 97
• Original Enrollment: Not Provided
• Actual Study Completion Date: June 2006
• Actual Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT00160290
• Other Study ID Numbers: S105.4.106
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: David Vilardell, Solvay Pharmaceuticals
• Original Responsible Party: Not Provided
• Current Study Sponsor: Solvay Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Global Clinical Director Solvay; Solvay Pharmaceuticals

• PRS Account: Solvay Pharmaceuticals
• Verification Date: April 2008