Early Phase 1 N=48

Users Study Of The Caverject Delivery System

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT01747928 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2014

Primary outcome: Primary: Delivery System Success Rate (DSSR) — 66.67; 66.67; 100.00; 100.00 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: dual-chamber syringe (Other)
Age: Adult, Older Adult · 40+ yrs
Sex: Male
Sponsor: Pfizer
Primary completion: Mar 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Delivery System Success Rate (DSSR)	66.67; 66.67; 100.00; 100.00; 100.00; 83.33	—
SECONDARY Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful?	5; 5; 6; 5; 6; 5	—
SECONDARY Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear?	5; 4; 6; 6; 6; 5	—
SECONDARY Number of Participants With Categorical Responses to the PAT: Most Difficult Step?	5; 3; 4; 5; 6; 4	—
SECONDARY Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use?	4; 3; 5; 6; 6; 5	—
SECONDARY Number of Participants Providing Responses to Any Question on the PAT	1; 1; 0; 0; 0; 1	—
SECONDARY Time Required to Perform Segments 1 to 5	148.8; 189.3; 176.0; 194.3; 246.5; 168.2	—
SECONDARY Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1	5; 6; 6; 6; 6; 5	—
SECONDARY Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3	5; 6; 6; 6; 6; 5	—
SECONDARY Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4	5; 6; 6; 6; 6; 5	—
SECONDARY Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6	5; 5; 6; 6; 6; 5	—
SECONDARY Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7	5; 5; 6; 6; 6; 5	—
SECONDARY Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9	5; 5; 6; 6; 6; 5	—
SECONDARY Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11	5; 5; 6; 6; 6; 5	—
SECONDARY Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12	5; 5; 6; 6; 6; 5	—
SECONDARY Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13	1; 1; 0; 0; 0; 0	—
SECONDARY Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b	5; 5; 6; 6; 6; 5	—
SECONDARY Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17	5; 5; 6; 0; 6; 5	—

Summary

Usability testing of the dual-chambered syringe in conjunction with the proposed patient instructions for use.

Eligibility Criteria

Inclusion Criteria

Healthy males

Exclusion Criteria

Inability to read English;
physical limitations preventing participant from operating the syringe

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01747928). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.