Brief title: Protocol title of the clinical trial intended
for the lay public.
Protocol number: A unique identification assigned to a Roche-sponsored trial. Each study has a unique number. Even if multiple studies are conducted using the same drug or diagnostic product, they will each have a unique number. A trial published in both the trial registry and the results database will have the same protocol number.
Sponsor: Name of sponsoring organization(s) that initiated the clinical investigation and which takes responsibility for the clinical trial.
Brief summary: A short description in lay terms of the
primary purpose of the clinical trial.
Official Scientific Title: Official name of the trial in scientific
terms provided by the study principal investigator or sponsor. This title
contains the following elements: intervention name, condition,
and outcome.
Study phase: See "Phase Definitions" section of this website. Study phases are not applicable to Diagnostic clinical trials.
Study type: Nature of the investigation; either "interventional" -
experimental studies in humans to investigate the safety and/or
efficacy of a new drug or treatment, or "observational" - studies
in humans that record specific events occurring in a defined
population without any intervention by a researcher
(such as psychosocial studies).
For interventional studies the following terms are used for describing the investigative techniques:
- Purpose: describes the rationale of the protocol, using the following terms:
- treatment: protocol evaluates intervention(s) for treatment of disease, syndrome or condition;
- prevention: protocol evaluates intervention(s) for preventing development of disease or condition;
- diagnosis: protocol evaluates intervention(s) aimed at identifying disease and condition;
- educational/counseling/training: protocol evaluates intervention(s) in an educational, counseling or training environment.
- Allocation: describes patient selection for intervention assignment, using the following terms:
- randomized: study participants are assigned to treatment / control groups by chance;
- non-randomized: study participants are assigned to treatment / control groups explicitly.
- Masking: describes the knowledge of investigators and study participants regarding the intervention assignment, using the following terms:
- open label: investigators and study participants know intervention assignment;
- single blind: investigators are aware of intervention assignment, study participants not;
- double blind: investigators and study participants are unaware of intervention assignment.
- Control: describes nature of comparison, using the following terms:
- placebo: study participants may receive placebo throughout study;
- active: study participants may receive a different treatment than treatment under investigation throughout study;
- uncontrolled: no controls are used in study.
- Assignment: describes how interventions are given to study participants, using the following terms:
- single group: all study participants receive same intervention;
- parallel: study participants receive one intervention during the study;
- crossover: study participants may receive different interventions sequentially during study;
- factorial: study participants may receive different numbers of interventions during study ranging from none to multiple;
- expanded access: A study which provides life-saving drugs which may still be in clinical trials to people who need immediate access to them.
- Endpoint: describes overall outcome that the protocol is designed to investigate, using the following terms:
- safety: evaluation of safety profile of intervention under proposed use;
- efficacy: measurement of effect of intervention on a disease / condition
- safety/efficacy: combination of safety and efficacy endpoints;
- pharmacokinetics: study of the effect of the body on a drug, in terms of absorption, distribution, metabolism and excretion;
- pharmacodynamics: study of the effects of a drug and its mechanism of action in the body over time;
- pharmacokinetics/dynamics: combination of pharmacokinetics and pharmacodynamics endpoints.
Overall study status: Current status of progress from
initiation to completion of clinical trial. Different status
stages are defined as:
- Not yet recruiting: participants in clinical trial
are not yet being recruited or enrolled in any site;
- Recruiting: participants in clinical trial are currently
being recruited and enrolled in at least one site;
- No longer recruiting: participants in clinical trial
are no longer being recruited or enrolled in any site;
- Completed: participants in clinical trial are no
longer being recruited; data analysis is complete;
- Suspended: recruiting or enrolling participants in
clinical trial has halted but potentially will resume;
- Terminated: recruiting or enrolling participants
in clinical trial has halted and will not resume.
Please note that the overall study status is updated on a monthly basis.
Condition: Primary diseases or conditions being studied.
Intervention type: Type of intervention being used
in study, from the following selection:
- Drug;
- Gene Transfer, including gene transfer and recombinant DNA
(e.g., human nerve growth factor);
- Vaccine;
- Behavior (e.g., protein and calorie controlled diet);
- Device (e.g., defibrillators);
- Procedure (e.g., adenoidectomy);
Intervention name: Precise generic name of the intervention
being evaluated.
Primary outcome: The measure or observation which is most clinically relevant to determine the effect of the intervention on key variables in the study.
Key secondary outcomes: Other measures or observations to determine the effect of the intervention on key variables in the study.
Eligibility criteria: Summary of criteria required for participation in the clinical study.
Gender: Gender eligibility for participating in study,
male, female or both.
Age limits: Minimum and maximum age limits for participants
in the clinical study.
Accepts healthy volunteers: Yes or No - answers question as to whether individuals who do not have the conditions or symptoms being studied may participate in the clinical trial.
Study start date: Planned beginning of enrollment.
Trial registration date: Date when study information was submitted to the trial registry for publication.
Date last updated: Time stamp indicating when information on the website was last updated. Every effort will be made to keep the information up to date.
Facility information: Location information on organizations
conducting clinical trials.
Please note that the facility information is updated on a monthly basis
Contact information: Email service provided to users who desire more information on specific clinical trials in the protocol registry.
