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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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hemorrhoids Anal Fissures | Drug: Lactulose Drug: Plantago ovata | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 97 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | March 2002 |
Actual Primary Completion Date : | June 2006 |
Actual Study Completion Date : | June 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: A
Lactulose Group
|
Drug: Lactulose
15 mL / 12 hours |
Active Comparator: B
Plantago Group
|
Drug: Plantago ovata
3,5 g / 12 hours |
- Quality of life of patients with hard stools and hemorrhoids or anal fissure [ Time Frame: 6 weeks ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00160290
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 |
Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
Responsible Party: | David Vilardell, Solvay Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00160290 |
Other Study ID Numbers: |
S105.4.106 |
First Posted: | September 12, 2005 Key Record Dates |
Last Update Posted: | May 6, 2008 |
Last Verified: | April 2008 |
lactulose randomised clinical trial hemorrhoids anal fissures |
Hemorrhoids Fissure in Ano Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
Vascular Diseases Cardiovascular Diseases Anus Diseases Lactulose Gastrointestinal Agents |