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:
Solvay Pharmaceuticals
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00160290
First received: September 9, 2005
Last updated: April 29, 2008
Last verified: April 2008
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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:
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00160290
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 Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |
Rectal Diseases Vascular Diseases Lactulose Gastrointestinal Agents Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015