Users Study Of The Caverject Delivery System

NCT01747928 | Completed Early Phase 1 Results

• 1 other identifier: A6711036
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

usability study

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1

Secondary Outcomes (22)

• Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful?

  Day 1

• Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear?

  Day 1

• Number of Participants With Categorical Responses to the PAT: Most Difficult Step?

  Day 1

• Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use?

  Day 1

• Number of Participants Providing Responses to Any Question on the PAT

  Day 1

Study Arms (1)

Group 1

EXPERIMENTAL

Other: dual-chamber syringe

Interventions

dual-chamber syringe OTHER

dual-chamber syringe for mock injection

Group 1

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Vince and Associates Clinical Research

Overland Park, Kansas, 66212, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

Limitations and Caveats

For outcome measure 7, the endpoint was originally the comments provided as part of the PAT. As clinicaltrials.gov do not support textual results, the number of participants who provided comments to any questions on the PAT are reported instead.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: December 12, 2012
• Study Start: March 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: May 2, 2014
• Results First Posted: May 2, 2014

Record last verified: 2014-04

Locations

US (1)