HemorrhoidsPhase 4NCT00160290
Trial to Evaluate Effect of Lactulose on Hard Stools in Patients With Hemorrhoids or Anal Fissures
A Phase 4 study testing Lactulose and Plantago ovata in people with Hemorrhoids and Anal Fissures, run by Solvay Pharmaceuticals at 8 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids, Anal Fissures
- What is being tested?
- Lactulose and Plantago ovata
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 8 sitesSpain
- Study dates
- Mar 2002to Jun 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from symptomatic hemorrhoids, or symptomatic anal fissure.
Who cannot join
- Patients suffering from malignant tumor in the intestine or the anal-rectal region, irritable colon, intestine inflammatory disease.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
Site 2
Barcelona
Site 6
Granada
Site 5
Huesca
Site 7
Oviedo
Site 4
Sabadell (Barcelona)
Site 3
Sant Cugat Del Vallès (Barcelona)
Site 8
Santiago de Compostela
Site 1
Valencia
About this study
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
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.
- Conditions
- Hemorrhoids, Anal Fissures
- Being tested
- Lactulose, Plantago ovata
- Keywords
- lactulose, randomised clinical trial, hemorrhoids, anal fissures
- Medical subject headings
- Hemorrhoids, Fissure in Ano
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactuloseDrug
15 mL / 12 hours
Plantago ovataDrug
3,5 g / 12 hours
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Lactulose Group Receives: Drug: Lactulose |
| B | Active comparator | Plantago Group Receives: Drug: Plantago ovata |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life of patients with hard stools and hemorrhoids or anal fissure
Measured: 6 weeks
Secondary outcomes (4)
Gastrointestinal Symptoms Rating Scale
Measured: 6 weeks
Bristol stool consistency scale
Measured: 6 weeks
Number of episodes of rectal bleeding
Measured: 6 weeks
Need of rescue medication
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMar 2002
- Primary completionJun 2006
- Study completionJun 2006
Why it stopped: This trial discontinued on 30 JUN 2006 due to a lack of enrolment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00160290
- Sponsor's protocol ID
- S105.4.106
- Status last verified
- Apr 2008
- First submitted
- 9 Sep 2005
- Last updated
- 6 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00160290
- Acronym / sponsor ID
- S105.4.106
- Conditions
- Hemorrhoids, Anal Fissures
- Keywords
- lactulose, randomised clinical trial, hemorrhoids, anal fissures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This trial discontinued on 30 JUN 2006 due to a lack of enrolment
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: LactuloseLactulose Group |
| B | Active comparator | Drug: Plantago ovataPlantago Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients suffering from symptomatic hemorrhoids, or symptomatic anal fissure.
Key exclusion criteria (1 listed)
- Patients suffering from malignant tumor in the intestine or the anal-rectal region, irritable colon, intestine inflammatory disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactulose15 mL / 12 hours | Drug | A |
| Plantago ovata3,5 g / 12 hours | Drug | B |
Primary outcome
Quality of life of patients with hard stools and hemorrhoids or anal fissure
Time frame: 6 weeks
4 secondary outcomes
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
Results and safety
The study was stopped early (reason given: This trial discontinued on 30 JUN 2006 due to a lack of enrolment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lactulose and Plantago ovata in people with Hemorrhoids and Anal Fissures, run by Solvay Pharmaceuticals at 8 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This trial discontinued on 30 JUN 2006 due to a lack of enrolment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life of patients with hard stools and hemorrhoids or anal fissure (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2008.