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

Condition(s) targeted: Hemorrhoids; Anal Fissures

Intervention: Lactulose (Drug); Plantago ovata (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Solvay Pharmaceuticals

Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals

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.

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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Quality of life of patients with hard stools and hemorrhoids or anal fissure

Secondary outcome:

Gastrointestinal Symptoms Rating Scale

Bristol stool consistency scale

Number of episodes of rectal bleeding

Need of rescue medication

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Site 1, Valencia, Spain

Site 2, Barcelona, Spain

Site 3, Sant Cugat del Vallès (Barcelona), Spain

Site 4, Sabadell (Barcelona), Spain

Site 5, Huesca, Spain

Site 6, Granada, Spain

Site 7, Oviedo, Spain

Site 8, Santiago de Compostela, Spain

Starting date: March 2002
Ending date: June 2006
Last updated: April 29, 2008