Papilloma Viral InfectionPhase 2NCT03584308
Efficacy of VIUSID® Plus GLIZIGEN® in Patients With Papilloma Virus Esophageal
A Phase 2 study testing Viusid® and Glizigen® in people with Papilloma Viral Infection and Papillomavirus Infections, run by Catalysis SL at 1 site in Cuba.
Trial summary
A randomized, double-blind, phase II clinical trial was conducted versus placebo in 110 patients with esophageal human papillomavirus. The experimental group will receive the VIUSID® plus GLIZIGEN® nutritional supplements, administered on an outpatient basis for 3 months. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Papilloma Viral Infection, Papillomavirus Infections, Esophageal Viral Wart
- What is being tested?
- Viusid® and Glizigen®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteCuba
- Study dates
- 15 Oct 2015to 15 Dec 2018
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older adults between 18 and 65 years of both sexes.
- Patients residing in the provinces of Havana, Artemisa and Mayabeque.
- Voluntariness of the patient to participate in the study. Informed and written consent.
- Women of childbearing age should have negative pregnancy test or use effective contraceptive methods such as intrauterine devices, hormonal contraceptives, barrier method or tubal ligation.
Who cannot join
- Pregnancy or breastfeeding.
- Contraindication to the performance of upper digestive endoscopy.
- Psychiatric conditions that do not favor the administration of treatment and follow-up.
- History of hypersensitivity to another similar product.
- Severe acute allergic states.
- Patients with concomitant diagnosis of esophageal tumor or other causes of infectious esophagitis.
- Present an associated chronic illness in the decompensation phase (heart disease, diabetes, hypertension, renal failure, AIDSl).
- Patients who are receiving another product under investigation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of VIUSID® Plus GLIZIGEN® in Patients With Papilloma Virus Esophageal. Phase II Clinical Trial
A randomized, double-blind, phase II clinical trial was conducted versus placebo in 110 patients with esophageal human papillomavirus. The experimental group will receive the VIUSID® plus GLIZIGEN® nutritional supplements, administered on an outpatient basis for 3 months. The control group will receive placebo from Viusid plus Glizigen placebo. It is expected that patients in the experimental group have a 30% higher rate of elimination of the virus than patients in the placebo group after treatment. The study will be conducted in the Superior Digestive Tract consultation of the Institute of Gastroenterology of Havana, Cuba.
Read the detailed description
Initially the study was planned as an adaptive study without seams, phase II / III for 150 patients. 75 in each therapeutic arm. The sample size was calculated with parameters of phase III studies, but establishing an early stop rule, with an intermediate analysis. For the calculation it was taken into account that the expected percentage of elimination of the virus by spontaneous remission in immunocompetent patients, reported internationally is on average 35%. It is intended that in the group of patients to whom VIUSID® plus GLIZIGEN® will be administered, this figure is ≥ 65%. In other words, it is desired to reach a minimum difference of approximately 30% between both groups. Considering a type I error of 5% (adjusted to 2.5% by an intermediate evaluation), a power of 90%, plus 5% of dropouts or losses to follow-up, the minimum number of patients to recruit is 150 patients in total , 75 in each therapeutic arm.
However, by decision of the promoter the study was stopped with 55 patients in each arm, 110 patients in total. And established as a phase II trial.
- Conditions
- Papilloma Viral Infection, Papillomavirus Infections, Esophageal Viral Wart, Esophageal Verrucous Carcinoma
- Being tested
- Viusid®, Glizigen®, Viusid Placebo, Glizigen Placebo
- Keywords
- Papillomavirus, Viusid, Glizigen, Papilloma virus Esophageal, Antioxidant
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viusid®Dietary supplement
The VIUSID nutritional supplement is presented in the form of envelopes and will be administered orally diluted in water, juice or milk, according to the patient's preference and will be administered 3 times a day, 15 minutes before breakfast, lunch and dinner.
Glizigen®Dietary supplement
The GLIZIGEN® product is presented in spray bottles and will be administered orally to swallow, away from meals 2 times a day.
Viusid PlaceboDietary supplement
The placebo of VIUSID nutritional supplement is presented in the form of envelopes and will be administered orally diluted in water, juice or milk, according to the patient's preference and will be administered 3 times a day, 15 minutes before breakfast, lunch and dinner .
Glizigen PlaceboDietary supplement
The placebo of GLIZIGEN® product is presented in spray bottles and will be administered orally to swallow, away from meals 2 times a day.
| Study group | Role | What they receive |
|---|---|---|
| Viusid® + Glizigen® | Experimental | The experimental arm will receive nutritional supplements Viusid + Glizigen Receives: Dietary Supplement: Viusid®; Dietary Supplement: Glizigen® |
| Placebo | Placebo comparator | The control group will receive a placebo of both (Viusid and Glizigen). Receives: Dietary Supplement: Viusid Placebo; Dietary Supplement: Glizigen Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement of the lesions of the virus in esophageal mucosal tissue sample
Absence of coilocytes / papilloma in the paraffin sample
Measured: 3 months
Clinical negativization of the virus in esophageal mucosal tissue sample
Negativization of the virus in fresh sample of the mucosa in the PCR study
Measured: 3 months
Secondary outcomes (6)
Evaluation of esophageal pathology
Acanthosis: Yes or No
Measured: 3 months
Evaluation of esophageal pathology
Papillary hyperplasia lamina propria: Yes or no
Measured: 3 months
Evaluation of esophageal pathology
Hyperplasia of the basal layer of the epithelium: Yes or No
Measured: 3 months
Evaluation of esophageal pathology
Dyskeratosis: Yes or No
Measured: 3 months
Evaluation of esophageal pathology
Dysplasia: Yes (Low Degree or High Degree) or No
Measured: 3 months
Toxicity due to the Treatment administered
It will be determined through the reporting of adverse events that are presented to the research product
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start15 Oct 2015
- Primary completion15 May 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papilloma Viral InfectionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random assignment, through a list obtained by computer. Patients will be randomized in the consultation of the upper digestive tract, once the anatomopathological result with the presence of coilocytes is received, and they meet the established selection criteria.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584308
- Sponsor's protocol ID
- VIUSID-GLIZ-PAPILOMA
- Status last verified
- Jun 2018
- First submitted
- 28 Jun 2018
- Last updated
- 22 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of VIUSID® Plus GLIZIGEN® in Patients With Papilloma Virus Esophageal. Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT03584308
- Acronym / sponsor ID
- VIUSID-GLIZ-PAPILOMA
- Conditions
- Papilloma Viral Infection, Papillomavirus Infections, Esophageal Viral Wart, Esophageal Verrucous Carcinoma
- Keywords
- Papillomavirus, Viusid, Glizigen, Papilloma virus Esophageal, Antioxidant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2015 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 12 Jul 2018 (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.
A randomized, double-blind, phase II clinical trial was conducted versus placebo in 110 patients with esophageal human papillomavirus. The experimental group will receive the VIUSID® plus GLIZIGEN® nutritional supplements, administered on an outpatient basis for 3 months. The control group will receive placebo from Viusid plus Glizigen placebo. It is expected that patients in the experimental group have a 30% higher rate of elimination of the virus than patients in the placebo group after treatment. The study will be conducted in the Superior Digestive Tract consultation of the Institute of Gastroenterology of Havana, Cuba.
Detailed description
Initially the study was planned as an adaptive study without seams, phase II / III for 150 patients. 75 in each therapeutic arm. The sample size was calculated with parameters of phase III studies, but establishing an early stop rule, with an intermediate analysis. For the calculation it was taken into account that the expected percentage of elimination of the virus by spontaneous remission in immunocompetent patients, reported internationally is on average 35%. It is intended that in the group of patients to whom VIUSID® plus GLIZIGEN® will be administered, this figure is ≥ 65%. In other words, it is desired to reach a minimum difference of approximately 30% between both groups. Considering a type I error of 5% (adjusted to 2.5% by an intermediate evaluation), a power of 90%, plus 5% of dropouts or losses to follow-up, the minimum number of patients to recruit is 150 patients in total , 75 in each therapeutic arm.
However, by decision of the promoter the study was stopped with 55 patients in each arm, 110 patients in total. And established as a phase II trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Random assignment, through a list obtained by computer. Patients will be randomized in the consultation of the upper digestive tract, once the anatomopathological result with the presence of coilocytes is received, and they meet the established selection criteria.
| Arm | Type | Receives |
|---|---|---|
| Viusid® + Glizigen® | Experimental | Dietary Supplement: Viusid®, Dietary Supplement: Glizigen®The experimental arm will receive nutritional supplements Viusid + Glizigen |
| Placebo | Placebo comparator | Dietary Supplement: Viusid Placebo, Dietary Supplement: Glizigen PlaceboThe control group will receive a placebo of both (Viusid and Glizigen). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Older adults between 18 and 65 years of both sexes.
- Patients residing in the provinces of Havana, Artemisa and Mayabeque.
- Voluntariness of the patient to participate in the study. Informed and written consent.
- Women of childbearing age should have negative pregnancy test or use effective contraceptive methods such as intrauterine devices, hormonal contraceptives, barrier method or tubal ligation.
Key exclusion criteria (8 listed)
- Pregnancy or breastfeeding.
- Contraindication to the performance of upper digestive endoscopy.
- Psychiatric conditions that do not favor the administration of treatment and follow-up.
- History of hypersensitivity to another similar product.
- Severe acute allergic states.
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 |
|---|---|---|
| Viusid®The VIUSID nutritional supplement is presented in the form of envelopes and will be administered orally diluted in water, juice or milk, according to the patient's preference and will be administered 3 times a day, 15 minutes before breakfast, lunch and dinner. | Dietary supplement | Viusid® + Glizigen® |
| Glizigen®The GLIZIGEN® product is presented in spray bottles and will be administered orally to swallow, away from meals 2 times a day. | Dietary supplement | Viusid® + Glizigen® |
| Viusid PlaceboThe placebo of VIUSID nutritional supplement is presented in the form of envelopes and will be administered orally diluted in water, juice or milk, according to the patient's preference and will be administered 3 times a day, 15 minutes before breakfast, lunch and dinner . | Dietary supplement | Placebo |
| Glizigen PlaceboThe placebo of GLIZIGEN® product is presented in spray bottles and will be administered orally to swallow, away from meals 2 times a day. | Dietary supplement | Placebo |
Primary outcome
Clinical improvement of the lesions of the virus in esophageal mucosal tissue sample
Time frame: 3 months
Absence of coilocytes / papilloma in the paraffin sample
Clinical negativization of the virus in esophageal mucosal tissue sample
Time frame: 3 months
Negativization of the virus in fresh sample of the mucosa in the PCR study
6 secondary outcomes
Evaluation of esophageal pathology
Time frame: 3 months
Evaluation of esophageal pathology
Time frame: 3 months
Evaluation of esophageal pathology
Time frame: 3 months
Evaluation of esophageal pathology
Time frame: 3 months
Evaluation of esophageal pathology
Time frame: 3 months
Toxicity due to the Treatment administered
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2019.
- Individual participant dataSharing planned: Yes
Related trials for Papilloma Viral Infection
Active, not recruiting
Communication Strategies to Increase HPV Vaccinations
Papilloma Viral Infection, Vaccine Hesitancy
Recruiting
Reducing Urban Cervical Cancer Disparities
Cervical Cancer, Papilloma Viral Infection
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Viusid® and Glizigen® in people with Papilloma Viral Infection and Papillomavirus Infections, run by Catalysis SL at 1 site in Cuba.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 22 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cuba. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical improvement of the lesions of the virus in esophageal mucosal tissue sample (time frame: 3 months). The study lists 2 primary outcomes in all. 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 22 May 2019; AzTrials last refreshed its copy on 8 Nov 2026.