Trial to Evaluate Effect of Lactulose on Hard Stools in P... | NCT00160290

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

NCT00160290

Sponsor

Solvay Pharmaceuticals

Status

Terminated

Last Update Posted

May 6, 2008Estimated

Enrollment

97Actual

Phase

Phase 4

Conditions

Hemorrhoids
Anal Fissures

Interventions

Lactulose
Plantago ovata

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This trial discontinued on 30 JUN 2006 due to a lack of enrolment

Expanded Access Info

Start Date

Mar 2002

Primary Completion Date

Jun 2006Actual

Completion Date

Jun 2006Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2008

Last Update Posted Date

May 6, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

97Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Lactulose Group	Drug: Lactulose
B	Active Comparator	Plantago Group	Drug: Plantago ovata

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lactulose	Drug	15 mL / 12 hours	A
Plantago ovata

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of life of patients with hard stools and hemorrhoids or anal fissure		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Gastrointestinal Symptoms Rating Scale		6 weeks
Bristol stool consistency scale		6 weeks
Number of episodes of rectal bleeding

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Director Solvay	Solvay Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Site 2		Barcelona			Spain
Site 6

Condition Browse Module

MeSH Terms

ID	Term
D006484	Hemorrhoids
D005401	Fissure in Ano

Ancestor Terms

ID	Term
D012002	Rectal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007792	Lactulose
D011620	Psyllium

Ancestor Terms

ID	Term
D004187	Disaccharides
D009844	Oligosaccharides
D011134	Polysaccharides
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided