Trial · Interventional
Status unknownPhase 4Registry dataNon-inferiority Evaluation of Pain Intensity After Biomatrop (Somatropin) Application in Relation to Hormotrop (Somatropin), in Healthy Subjects
Overview
- Status
- Status unknown
- Phase
- Phase 4
- Enrollment
- 68 participants (estimated)
- Sponsor
- Ache Laboratorios Farmaceuticos S.A. · Industry
- Design
- Randomized · Quadruple masking
- Countries
1 country
Brazil
- Start
- 27 Aug 2018 (estimated)
- Primary completion
- Sept 2018 (estimated)
- Completion
- Oct 2018 (estimated)
- First posted
- 16 Aug 2018
- Last update posted
- 17 Aug 2018
- Conditions
- Healthy Subjects
Timeline
1 trial
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Non-inferiority Evaluation of Pain Intensity After Biomatrop (Somatropin) Application in Relation to Hormotrop (Somatropin), in Healthy Subjects
NCT03634514est. 27 Aug 2018 to est. Oct 2018
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Recombinant human growth hormone - BiomatropDrug
- Recombinant human growth hormone - HormotropDrug
Arms2
Experimental
Application of Biomatrop
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.
Active comparator
Application of Hormotrop
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
Pain Intensity
Time frame · 1 hour
Registry description
Report the Pain Intensity using Visual Analogue Scale (0-10cm)
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 50 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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