HealthyEarly Phase 1NCT01747928
Users Study Of The Caverject Delivery System
A Early Phase 1 study testing dual-chamber syringe in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
Usability testing of the dual-chambered syringe in conjunction with the proposed patient instructions for use. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- dual-chamber syringe
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Mar 2013
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males
Who cannot join
- Inability to read English;
- physical limitations preventing participant from operating the syringe
Trial locations and contacts
1 site in 1 country.
United States1 site
Vince and Associates Clinical Research
Overland Park, Kansas, 66212
About this study
Official title: A Representative Users Study Of The Operating Characteristics Of The Caverject Delivery System
Usability testing of the dual-chambered syringe in conjunction with the proposed patient instructions for use.
Read the detailed description
Usability testing of the dual-chambered syringe in conjunction with the proposed patient instructions for use
- Conditions
- Healthy
- Being tested
- dual-chamber syringe
- Keywords
- usability study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual-chamber syringeOther
dual-chamber syringe for mock injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Other: dual-chamber syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery System Success Rate (DSSR)
DSSR was defined as percentage of participants who were able to successfully expel the selected dose from the Caverject Impulse Dual Chamber Delivery System when relying on the modified Instructions for Use (IFU). The process was considered successful if the attempt was observed and documented by study personnel AND the participant didn't receive any operational/"hands on" demonstration on how to operate the plunger from study personnel AND after performing all preparatory steps, the participant was able to expel the dose to the selected plunger stop-point without any unexpected interruption.
Measured: Day 1
Secondary outcomes (22)
Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful?
Participant responses were reported as follows: Very Useful, Somewhat Useful, Not Very Useful, Not Useful At All.
Measured: Day 1
Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear?
Participant responses were reported as follows: Very clear, Somewhat clear, Not very clear, Not clear at all.
Measured: Day 1
Number of Participants With Categorical Responses to the PAT: Most Difficult Step?
Participant responses were reported as follows: No steps really difficult, Attaching needle, Mixing the solution, Getting the air out of syringe, Setting the dose, Pushing plunger, Other.
Measured: Day 1
Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use?
Participant responses were reported as follows: Very easy, Somewhat easy, Somewhat difficult, Very difficult.
Measured: Day 1
Number of Participants Providing Responses to Any Question on the PAT
Number of participants providing responses on questions in the PAT. Questions were as follows: What step did you stop? Why?; Instructions provided were useful?; Instructions provided were clear?; Most difficult step?; Syringe easy to use?
Measured: Day 1
Time Required to Perform Segments 1 to 5
Steps involved while using the Caverject Impulse Delivery System were categorized into segments: Segment 1 (Assembly While Using the Caverject Impulse Delivery System), Segment 2 (Mixing the Solution), Segment 3 (De-aerating the Syring While Using the Caverject Impulse Delivery System), Segment 4 (Setting the Dose) and Segment 5 (Performing the Injection While Using the Caverject Impulse Delivery System).
Measured: Day 1
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1
OAT, Q1: Participant assembled the components correctly. Observer responses were reported as follows: Yes, No. A "No" answer indicated failure according to the OAT. Q1 and Q2 made up Segment 1: Assembly of Components.
Measured: Day 1
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2
OAT, Q2: Evidence of mechanical malfunction or defect for Segment 1. Observer responses were reported as follows: Yes, No. Q1 and Q2 made up Segment 1: Assembly of Components.
Measured: Day 1
Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3
OAT, Q3: Participant performed mixing step correctly. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the OAT. Q3 to Q5 made up Segment 2: Mixing the Solution.
Measured: Day 1
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4
OAT, Q4: Participant positioned piston correctly. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the SAP. Q3 to Q5 made up Segment 2: Mixing the Solution.
Measured: Day 1
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5
OAT, Q5: Evidence of mechanical malfunction/defect for Segment 2. Observer responses were reported as follows: Yes, No. Q3 to Q5 made up Segment 2: Mixing the Solution.
Measured: Day 1
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6
OAT, Q6: De-aeration step performed successfully. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the OAT. Q6 to Q8 made up Segment 3: De-aeration of the Syringe.
Measured: Day 1
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7
OAT, Q7: Participant depressed the plunger correctly to de-aerate the syringe. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the SAP. Q6 to Q8 made up Segment 3: De-aeration of the Syringe.
Measured: Day 1
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8
OAT, Q8: Evidence of mechanical malfunction/defect for Segment 3. Observer responses were reported as follows: Yes, No. Q6 to Q8 made up Segment 3: De-aeration of the Syringe.
Measured: Day 1
Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9
OAT, Q9: Participant was able to set a dose (any dose) for delivery. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the OAT. Q9 and Q10 made up Segment 4: Setting the Dose.
Measured: Day 1
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10
OAT, Q10: Evidence of mechanical malfunction/defect for Segment 4. Observer responses were reported as follows: Yes, No. Q9 and Q10 made up Segment 4: Setting the Dose.
Measured: Day 1
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11
OAT, Q11: Participant successfully set the correct dose (as assigned). Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the OAT. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Measured: Day 1
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12
OAT, Q12: Participant successfully expelled the dose into the target. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the OAT. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Measured: Day 1
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13
OAT, Q13: Was there any difficulty/obstruction encountered in expelling dose? Observer responses were reported as follows: Yes, No. A "Yes" response indicated failure according to the SAP. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Measured: Day 1
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b
OAT, Q14b: Participant successfully expelled/injected the assigned dose (per Dose Card). Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Measured: Day 1
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16
OAT, Q16: Evidence of mechanical malfunction/defect. Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Measured: Day 1
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17
OAT, Q17: Participant understood reason excess liquid was present after a partial-dose injection. Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startMar 2013
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Early Phase 1
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747928
- Sponsor's protocol ID
- A6711036
- Status last verified
- Apr 2014
- First submitted
- 20 Nov 2012
- Last updated
- 2 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Representative Users Study Of The Operating Characteristics Of The Caverject Delivery System
- ClinicalTrials.gov ID
- NCT01747928
- Acronym / sponsor ID
- A6711036
- Conditions
- Healthy
- Keywords
- usability study
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 12 Dec 2012 (estimated)
- Results
- Posted 2 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Usability testing of the dual-chambered syringe in conjunction with the proposed patient instructions for use.
Detailed description
Usability testing of the dual-chambered syringe in conjunction with the proposed patient instructions for use
Study design
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: dual-chamber syringe |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy males
Key exclusion criteria (2 listed)
- Inability to read English;
- physical limitations preventing participant from operating the syringe
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 |
|---|---|---|
| dual-chamber syringedual-chamber syringe for mock injection | Other | Group 1 |
Primary outcome
Delivery System Success Rate (DSSR)
Time frame: Day 1
DSSR was defined as percentage of participants who were able to successfully expel the selected dose from the Caverject Impulse Dual Chamber Delivery System when relying on the modified Instructions for Use (IFU). The process was considered successful if the attempt was observed and documented by study personnel AND the participant didn't receive any operational/"hands on" demonstration on how to operate the plunger from study personnel AND after performing all preparatory steps, the participant was able to expel the dose to the selected plunger stop-point without any unexpected interruption.
22 secondary outcomes
Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful?
Time frame: Day 1
Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear?
Time frame: Day 1
Number of Participants With Categorical Responses to the PAT: Most Difficult Step?
Time frame: Day 1
Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use?
Time frame: Day 1
Number of Participants Providing Responses to Any Question on the PAT
Time frame: Day 1
Time Required to Perform Segments 1 to 5
Time frame: Day 1
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1
Time frame: Day 1
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2
Time frame: Day 1
Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3
Time frame: Day 1
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4
Time frame: Day 1
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5
Time frame: Day 1
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6
Time frame: Day 1
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7
Time frame: Day 1
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8
Time frame: Day 1
Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9
Time frame: Day 1
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10
Time frame: Day 1
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11
Time frame: Day 1
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12
Time frame: Day 1
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13
Time frame: Day 1
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b
Time frame: Day 1
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16
Time frame: Day 1
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing dual-chamber syringe in people with Healthy, run by Pfizer at 1 site in United States.
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 1 inclusion and 2 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 2 May 2014. 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 United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Delivery System Success Rate (DSSR) (time frame: Day 1). 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 2 May 2014.