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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Cuba1 site

  • Gastroenterology Institute

    Vedado, La Habana, 10600

Other trials in Cuba

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.

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 groups in NCT03584308
Study groupRoleWhat they receive
Viusid® + Glizigen®ExperimentalThe experimental arm will receive nutritional supplements Viusid + Glizigen
Receives: Dietary Supplement: Viusid®; Dietary Supplement: Glizigen®
PlaceboPlacebo comparatorThe 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.

  1. Clinical improvement of the lesions of the virus in esophageal mucosal tissue sample

    Absence of coilocytes / papilloma in the paraffin sample

    Measured: 3 months

  2. 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)

  1. Evaluation of esophageal pathology

    Acanthosis: Yes or No

    Measured: 3 months

  2. Evaluation of esophageal pathology

    Papillary hyperplasia lamina propria: Yes or no

    Measured: 3 months

  3. Evaluation of esophageal pathology

    Hyperplasia of the basal layer of the epithelium: Yes or No

    Measured: 3 months

  4. Evaluation of esophageal pathology

    Dyskeratosis: Yes or No

    Measured: 3 months

  5. Evaluation of esophageal pathology

    Dysplasia: Yes (Low Degree or High Degree) or No

    Measured: 3 months

  6. 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.

  1. First posted12 Jul 2018
  2. Study start15 Oct 2015
  3. Primary completion15 May 2018
  4. Study completion15 Dec 2018

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT03584308.

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.

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