Trial to Evaluate Effect of Lactulose on Hard Stools in Patients With Hemorrhoids or Anal Fissures
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ClinicalTrials.gov Identifier: NCT00160290 |
Recruitment Status :
Terminated
(This trial discontinued on 30 JUN 2006 due to a lack of enrolment)
First Posted : September 12, 2005
Last Update Posted : May 6, 2008
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Sponsor:
Solvay Pharmaceuticals
Information provided by:
Solvay Pharmaceuticals
Tracking Information | ||||
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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 |
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 | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | 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 ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
97 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | June 2006 | |||
Actual Primary Completion Date | June 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | 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 ICMJE | Not Provided | |||
Current Responsible Party | David Vilardell, Solvay Pharmaceuticals | |||
Original Responsible Party | Not Provided | |||
Current Study Sponsor ICMJE | Solvay Pharmaceuticals | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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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 |