Healthy SubjectsPhase 4NCT03634514
Non-inferiority Evaluation of Pain Intensity After Biomatrop (Somatropin) Application in Relation to Hormotrop (Somatropin), in Healthy Subjects
A Phase 4 study testing Recombinant human growth hormone - Biomatrop and Recombinant human growth hormone - Hormotrop in people with Healthy Subjects, run by Ache Laboratorios Farmaceuticos S.A. at 1 site in Brazil.
Trial summary
Randomized, Double-blind, Controlled, Crossover, in which 68 subjects (34 males and 34 females) will receive, in each stage, an application of 4 UI, subcutaneous, single dose, of the investigational drug (Recombinant Human Somatropin - Biomatrop) and the comparator (Recombinant Human Somatropin - Hormotrop) according… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Recombinant human growth hormone - Biomatrop and Recombinant human growth hormone - Hormotrop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Aug 2018to Oct 2018
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Skin phototype from 2 to 4, according to Fitspatrick classification: http://www.sbd.org.br/dermatologia/pele/cuidados/classifica cao-dos-fototipos-de-pele/ ;
- Subjects with normal laboratory, type 1 urine exam, vital signs and ECG results;
- Weight ≥ 50kg and Body Mass Index ≤ 30 ;
- Healthy subject according with clinical history
- Ability to understand and consent their participation in this clinical study, expressed by signing the Informed Consent Form (ICF);
- Subject who have negative results for stool protoparasitological examination accomplished in clinical study. Subjects with positive results for Endolimax nana, Entamoeba hartmanni, Entamoeba coli, Iodamoeva btshlii, Chilomastix mesili, Trichomonas hominis, Retortamonas intestinalis e Enteromonas hominis will be able to be included in the study. At the end of the study those subjects will be guided to treatment according to clinic investigator criteria.
Who cannot join
- Laboratory and clinical exam results out of normal range values, unless considered by physician clinically irrelevant;
- Positive sorology for HIV;
- Positive sorology for Hepatitis B;
- Positive sorology for Hepatitis C;
- Known hypersensitivity to the components of the medicines used during the study or related chemical compounds;
- Subjects that has participated in clinical trial protocols in the last twelve (12) months (National Board of Health- Resolution 251 of 07 August 1997, Part III, sub-item J), unless the investigator considers that there may be a direct benefit to it;
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- Use of any type of regular medication within two (2) weeks or five (5) half-lives (whichever lasts longer) before administration of the first dose of the investigational product (IP). The eventual use of medication, which in the opinion of the Principal Investigator or physician does not interfere with the pharmacokinetics of IP in study will not be considered as exclusion criteria;
- History of alcohol abuse or having ingested alcoholic drink 24 hours prior to IP administration;
- History of psychotropic drug use and / or positive outcome for any of the components of the drug abuse test for amphetamine, benzoylecgonine (cocaine), benzodiazepines, methamphetamine, opiates, morphine, etrahydrocannabinol-THC (Marijuana / Marijuana). Subjects who used marijuana and hashish in less than three months before the consultation will be excluded. For drugs like cocaine, crack and heroin will be excluded subjects who present any use history;
- Any finding of clinical observation, laboratory abnormality or therapy which, in the opinion of the investigator, may put the subject at risk or interfere with the purpose of the study;
- The subject have any condition that in investigator's opinion prevents him/her from participating in the study;
- History of food allergy or hyperactivity to medications or food;
- Regular smokers or ex-smokers who have stopped for less than 6 months;
- Subjects who have a relationship of kinship to second degree or any bond with the sponsor or research center employees;
- Subjects with the following ECG changes: sinus tachycardia with heart rate ˃ 120 bpm; bradycardia sinus heart rate <50 bpm; atrial tachycardia, ventricular or junctional; ectopic atrial rhythm; atrial fibrillation; atrial flutter; accelerated idioventricular rhythm; locking atrium ventricular (BAV) of 1º, 2º and 3º degrees; ventricular pre-excitation; complete blockage of right or left branch; rhythm of pacemaker; supraventricular tachycardia (nodal tachycardia, ventricular atrial tachycardia) or any other clinically significant;
- Male subjects who do not agree to use acceptable contraceptive methods: (a) contraceptive methods for the participant: barrier preservative, except for (vasectomy) or for participants who declare that they do not engage in sexual practices or exercise them non-reprodutively; (b) contraceptive methods for the partner: oral contraceptive, intravenous contraceptive, intrauterine device (IUD), hormonal implant, hormonal transdermal patch, tubal ligation, and barrier methods except for female partners that are surgically sterile (bilateral oophorectomy or hysterectomy), or menopause for at least 01 (one) year;
- Women who do not agree to use acceptable contraceptive methods (oral contraceptive, intravenous contraceptive, intrauterine device (IUD), hormonal implant, barrier methods, hormonal transdermal patch and tubal ligation); except for those surgically sterile (bilateral oophorectomy or hysterectomy), menopause for at least one year, and participants who report not engaging in sexual practices or non-reproductive practices;
- Women in pregnancy or nursing period.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Ciências Farmacêuticas
Goiânia, Goiás
Sérgio Vencio, +55 62 3240-1900, sergio.vencio@icf.com.br
About this study
Official title: National, Monocentric, Randomized, Double-blind, Controlled, Crossover Clinical Trial, to Evaluate the Non-inferiority of Pain Intensity After the Application of Recombinant Human Somatropin - Biomatrop (Biosintética Farmacêutica) in Relation to Recombinant Human Somatotropin - Hormotrop (Bergamo), Single Dose, in Healthy Subjects of Both Genders
Randomized, Double-blind, Controlled, Crossover, in which 68 subjects (34 males and 34 females) will receive, in each stage, an application of 4 UI, subcutaneous, single dose, of the investigational drug (Recombinant Human Somatropin - Biomatrop) and the comparator (Recombinant Human Somatropin - Hormotrop) according to randomization to evaluate the Non-inferiority of Pain Intensity After the Application of Hormotrop, using Visual Analogue Scale (0-10cm) and record the incidence of adverse events.
- Conditions
- Healthy Subjects
- Being tested
- Recombinant human growth hormone - Biomatrop, Recombinant human growth hormone - Hormotrop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human growth hormone - BiomatropDrug
The subjects who recieve Biomatrop first, after a period maximum of 24 hours will recieve a dose of Hormotrop.
Recombinant human growth hormone - HormotropDrug
The subjects who recieve Hormotrop first, after a period maximum of 24 hours will recieve a dose of Biomatrop.
| Study group | Role | What they receive |
|---|---|---|
| Application of Biomatrop | Experimental | A single dose of Recombinant Human Somatropin - Biomatrop is administered. The pain intensity is evaluated using visual analogue scale (0-10cm) and record the incidence of adverse events. Receives: Drug: Recombinant human growth hormone - Biomatrop; Drug: Recombinant human growth hormone - Hormotrop |
| Application of Hormotrop | Active comparator | A single dose of Recombinant Human Somatropin - Hormotrop is administered. The pain intensity is evaluated using visual analogue scale (0-10cm) and record the incidence of adverse events. Receives: Drug: Recombinant human growth hormone - Biomatrop; Drug: Recombinant human growth hormone - Hormotrop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Report the Pain Intensity using Visual Analogue Scale (0-10cm)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start27 Aug 2018 (estimated)
- Primary completionSep 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sérgio Alberto Cunha Vêncio, Principal investigator, Instituto de Ciências Farmacêuticas (ICF)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634514
- Sponsor's protocol ID
- PPES 002/18
- Status last verified
- Aug 2018
- First submitted
- 13 Aug 2018
- Last updated
- 17 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National, Monocentric, Randomized, Double-blind, Controlled, Crossover Clinical Trial, to Evaluate the Non-inferiority of Pain Intensity After the Application of Recombinant Human Somatropin - Biomatrop (Biosintética Farmacêutica) in Relation to Recombinant Human Somatotropin - Hormotrop (Bergamo), Single Dose, in Healthy Subjects of Both Genders
- ClinicalTrials.gov ID
- NCT03634514
- Acronym / sponsor ID
- PPES 002/18
- Conditions
- Healthy Subjects
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2018 (estimated)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 16 Aug 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.
Randomized, Double-blind, Controlled, Crossover, in which 68 subjects (34 males and 34 females) will receive, in each stage, an application of 4 UI, subcutaneous, single dose, of the investigational drug (Recombinant Human Somatropin - Biomatrop) and the comparator (Recombinant Human Somatropin - Hormotrop) according to randomization to evaluate the Non-inferiority of Pain Intensity After the Application of Hormotrop, using Visual Analogue Scale (0-10cm) and record the incidence of adverse events.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Application of Biomatrop | Experimental | Drug: Recombinant human growth hormone - Biomatrop, Drug: Recombinant human growth hormone - HormotropA single dose of Recombinant Human Somatropin - Biomatrop is administered. The pain intensity is evaluated using visual analogue scale (0-10cm) and record the incidence of adverse events. |
| Application of Hormotrop | Active comparator | Drug: Recombinant human growth hormone - Biomatrop, Drug: Recombinant human growth hormone - HormotropA single dose of Recombinant Human Somatropin - Hormotrop is administered. The pain intensity is evaluated using visual analogue scale (0-10cm) and record the incidence of adverse events. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Skin phototype from 2 to 4, according to Fitspatrick classification: http://www.sbd.org.br/dermatologia/pele/cuidados/classifica cao-dos-fototipos-de-pele/ ;
- Subjects with normal laboratory, type 1 urine exam, vital signs and ECG results;
- Weight ≥ 50kg and Body Mass Index ≤ 30 ;
- Healthy subject according with clinical history
- Ability to understand and consent their participation in this clinical study, expressed by signing the Informed Consent Form (ICF);
Key exclusion criteria (18 listed)
- Laboratory and clinical exam results out of normal range values, unless considered by physician clinically irrelevant;
- Positive sorology for HIV;
- Positive sorology for Hepatitis B;
- Positive sorology for Hepatitis C;
- Known hypersensitivity to the components of the medicines used during the study or related chemical compounds;
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 |
|---|---|---|
| Recombinant human growth hormone - BiomatropThe subjects who recieve Biomatrop first, after a period maximum of 24 hours will recieve a dose of Hormotrop. | Drug | Application of Biomatrop, Application of Hormotrop |
| Recombinant human growth hormone - HormotropThe subjects who recieve Hormotrop first, after a period maximum of 24 hours will recieve a dose of Biomatrop. | Drug | Application of Biomatrop, Application of Hormotrop |
Primary outcome
Pain Intensity
Time frame: 1 hour
Report the Pain Intensity using Visual Analogue Scale (0-10cm)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
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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.
Sérgio Alberto Cunha Vêncio principal investigator
Instituto de Ciências Farmacêuticas (ICF)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Recombinant human growth hormone - Biomatrop and Recombinant human growth hormone - Hormotrop in people with Healthy Subjects, run by Ache Laboratorios Farmaceuticos S.A. at 1 site in Brazil.
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 6 inclusion and 18 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 17 Aug 2018. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisangela Rorato (+55 11 2608-6130, Elisangela.rorato@ache.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: 1 hour). 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 17 Aug 2018.