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NCT00160290 Clinical Trial

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

Hemorrhoids Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00160290
Other study ID # S105.4.106
Secondary ID
Status Terminated
Phase Phase 4
First received September 9, 2005
Last updated April 29, 2008
Start date March 2002
Est. completion date June 2006

Study information
Verified date April 2008
Source Solvay Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Spain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 97
Est. completion date June 2006
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lactulose
15 mL / 12 hours
• Plantago ovata
3,5 g / 12 hours

Locations
Country Name City State
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

Sponsors (1)
Lead Sponsor Collaborator
Solvay Pharmaceuticals

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of life of patients with hard stools and hemorrhoids or anal fissure 6 weeks No
Secondary Gastrointestinal Symptoms Rating Scale 6 weeks No
Secondary Bristol stool consistency scale 6 weeks No
Secondary Number of episodes of rectal bleeding 6 weeks No
Secondary Need of rescue medication 6 weeks No
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