Bleeding AnalPhase 3NCT04362384
Topical Vitamin E Ovules for the Treatment of Hemorrhoids
A Phase 3 study testing Vitamin E ovules and Prednisolone ointment in people with Bleeding Anal and Pain, run by Hospital General Universitario Elche.
Trial summary
Patients with hemorrohoids grade II and III were included. Patients were randomized into 2 groups: Experimental group: Patients will receive a treatment with vitamin E ovules, which must be placed inside the annus Control group: Patients will receive a treatment with corticoid ointment, with endoanal application… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding Anal, Pain, Stings
- What is being tested?
- Vitamin E ovules and Prednisolone ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2020to 30 Oct 2020
- Phase
- Phase 3
- 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
- Grade II and III hemorrhoids
Who cannot join
- Grade I or IV hemorrhoids
- Patients with previous anal surgeries
- Patients having received previous pharmacological treatments for hemorrhoids
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Topical Endorectal Vietamin E Ovules for the Treatment of Grade 2 and 3 Hemorrhoids
Patients with hemorrohoids grade II and III were included. Patients were randomized into 2 groups:
- Experimental group: Patients will receive a treatment with vitamin E ovules, which must be placed inside the annus
- Control group: Patients will receive a treatment with corticoid ointment, with endoanal application
Bleeding, pain and stinging will be evaluated 14 days after beginning the treatment.
Read the detailed description
Patients with hemorrohoids grade II and III were included.
Patients were randomized into 2 groups:
- Experimental group: Patients will receive a treatment with vitamin E ovules, which must be placed inside the annus. 1 ovule must be inserted daily during 14 days.
- Control group: Patients will receive a treatment with prednisolone ointment, with endoanal application 3 times per day during 14 days.
Bleeding, pain and stinging will be evaluated 14 days after beginning the treatment. Quantification of pain will be performed following a visual analogic scale ranging from 0 (absence of symptoms) to 100 (unbearable symptoms).
- Conditions
- Bleeding Anal, Pain, Stings
- Being tested
- Vitamin E ovules, Prednisolone ointment
- Medical subject headings
- Gastrointestinal Hemorrhage, Pain, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin E ovulesDrug
Endoanal vitamin E ovules will be prescribed
Prednisolone ointmentDrug
Endoanal Prednisolone ointment will be prescribed
| Study group | Role | What they receive |
|---|---|---|
| Vitamin E ovules | Experimental | Endoanal Vitamin E ovules will be prescriped during 14 days Receives: Drug: Vitamin E ovules |
| Prednisolone ointment | Active comparator | Endoanal Prednisolone ointment will be prescriped during 14 days Receives: Drug: Prednisolone ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of patients with Bleeding
The patient refers rectal bleeding during defecation (patients´self-report) or active bleeding is observed at rectal examination. The variable will be measured as present (1) or absent(0)
Measured: 14 days after beginning the treatment
Secondary outcomes (2)
Anal pain assessed by Visual Analogic Scale
The patients will be asked to quantify their perception of pain on a VAS, ranging from 0mm(absence of pain) to 100mm (unbearable pain)
Measured: 14 days after beginning the treatment
% of patients with Stinging
The patient refers stinging sensation (patients´self-report) . The variable will be measured as present (1) or absent(0)
Measured: 14 days after beginning the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 May 2020 (estimated)
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bleeding AnalStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
- Investigators
- Jaime Ruiz Tovar Polo, Principal investigator, Garcilaso Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362384
- Sponsor's protocol ID
- Garcilaso 2020/2
- Status last verified
- Apr 2020
- First submitted
- 19 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Endorectal Vietamin E Ovules for the Treatment of Grade 2 and 3 Hemorrhoids
- ClinicalTrials.gov ID
- NCT04362384
- Acronym / sponsor ID
- Garcilaso 2020/2
- Conditions
- Bleeding Anal, Pain, Stings
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 24 Apr 2020 (actual)
- 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.
Patients with hemorrohoids grade II and III were included. Patients were randomized into 2 groups:
- Experimental group: Patients will receive a treatment with vitamin E ovules, which must be placed inside the annus
- Control group: Patients will receive a treatment with corticoid ointment, with endoanal application
Bleeding, pain and stinging will be evaluated 14 days after beginning the treatment.
Detailed description
Patients with hemorrohoids grade II and III were included.
Patients were randomized into 2 groups:
- Experimental group: Patients will receive a treatment with vitamin E ovules, which must be placed inside the annus. 1 ovule must be inserted daily during 14 days.
- Control group: Patients will receive a treatment with prednisolone ointment, with endoanal application 3 times per day during 14 days.
Bleeding, pain and stinging will be evaluated 14 days after beginning the treatment. Quantification of pain will be performed following a visual analogic scale ranging from 0 (absence of symptoms) to 100 (unbearable symptoms).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin E ovules | Experimental | Drug: Vitamin E ovulesEndoanal Vitamin E ovules will be prescriped during 14 days |
| Prednisolone ointment | Active comparator | Drug: Prednisolone ointmentEndoanal Prednisolone ointment will be prescriped during 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Grade II and III hemorrhoids
Key exclusion criteria (3 listed)
- Grade I or IV hemorrhoids
- Patients with previous anal surgeries
- Patients having received previous pharmacological treatments for hemorrhoids
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 |
|---|---|---|
| Vitamin E ovulesEndoanal vitamin E ovules will be prescribed | Drug | Vitamin E ovules |
| Prednisolone ointmentEndoanal Prednisolone ointment will be prescribed | Drug | Prednisolone ointment |
Primary outcome
% of patients with Bleeding
Time frame: 14 days after beginning the treatment
The patient refers rectal bleeding during defecation (patients´self-report) or active bleeding is observed at rectal examination. The variable will be measured as present (1) or absent(0)
2 secondary outcomes
Anal pain assessed by Visual Analogic Scale
Time frame: 14 days after beginning the treatment
% of patients with Stinging
Time frame: 14 days after beginning the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
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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.
Jaime Ruiz Tovar Polo principal investigator
Garcilaso Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin E ovules and Prednisolone ointment in people with Bleeding Anal and Pain, run by Hospital General Universitario Elche.
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 3 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: status not confirmed, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaime Ruiz-Tovar (630534808, jruiztovar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of patients with Bleeding (time frame: 14 days after beginning the treatment). 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 24 Apr 2020.