Clinical Trials Protocol Template

Clinical Trials Protocol Template

Protocol Number: MAP-7189 Version 1.3; 28 December 2017 CLINICAL STUDY PROTOCOL A Randomized, Multi-Center, Double-blind, Placebo Controlled, Parallel Group Trial to Evaluate Efficacy and Safety of Mayne Pharma’s Ivermectin 0.5% Lotion Compared to Sklice® Ivermectin 0.5% Lotion in the Treatment of Head Lice Protocol Identifying Number: MAP-7189 Sponsor: Mayne Pharma, LLC 1240 Sugg Parkway, Greenville, NC 27834 USA Phone: +1 (252) 717-1382 Fax: +1 (252) 758-8522 Funded by: Mayne Pharma, LLC Protocol Version 1.3; 28 December2017 1 Protocol Number: MAP-7189 Version 1.3; 28 December 2017 Table of Contents SIGNATURE PAGE.............................................................................................................................................. 2 Table of Contents ................................................................................................................................................. 3 Protocol Amendment 2 Summary of Changes....................................................................................................... 6 Protocol Amendment 1 Summary of Changes....................................................................................................... 7 List of Abbreviations ............................................................................................................................................. 8 INVESTIGATOR SIGNATURE PAGE ................................................................................................................... 9 Synopsis ............................................................................................................................................................ 10 1 Key Roles .............................................................................................................................................. 16 2 Study Introduction ........................................................................................................................................... 17 2.1 Background Information .............................................................................................................................. 17 2.2 Rationale .................................................................................................................................................... 17 2.3 Potential Risks and Benefits ........................................................................................................................ 18 2.3.1 Known Potential Risks ............................................................................................................................ 18 2.3.2 Known Potential Benefits ........................................................................................................................ 18 3 Objectives and Purpose ................................................................................................................................... 19 4 Study Design and Endpoints ............................................................................................................................ 19 4.1 Description of the Study Design .................................................................................................................. 19 4.2 Study Endpoint ........................................................................................................................................... 20 4.2.1 Primary Endpoint .................................................................................................................................... 20 4.2.2. Secondary Endpoint .............................................................................................................................. 20 5 Study Enrollment and Withdrawal .................................................................................................................... 20 5.1 Inclusion Criteria ......................................................................................................................................... 20 5.2 Exclusion Criteria ........................................................................................................................................ 21 5.3 Criteria for Inclusion of Minor Subjects ........................................................................................................ 22 5.4 Strategies for Recruitment and Retention .................................................................................................... 22 5.5 Subject Withdrawal and Termination ........................................................................................................... 22 5.5.1 Potential Reasons for Withdrawal ........................................................................................................... 22 5.5.2 Handling of Subject Withdrawals or Termination ..................................................................................... 23 5.6 Premature Suspension or Termination of Study .......................................................................................... 23 6 Study Drug ...................................................................................................................................................... 24 6.1 Study Agent (s) and Control Description ...................................................................................................... 24 6.1.1 Acquisition .............................................................................................................................................. 24 6.1.2 Formulation, Appearance, Packaging and Labeling ................................................................................. 24 6.1.3 Product Storage and Stability .................................................................................................................. 24 3 Protocol Number: MAP-7189 Version 1.3; 28 December 2017 6.1.4 Preparation ............................................................................................................................................. 24 6.1.5 Dosing and Administration ...................................................................................................................... 25 6.1.6 Route of Administration ........................................................................................................................... 25 6.1.7 Blinding .................................................................................................................................................. 25 6.1.8 Duration of Therapy ................................................................................................................................ 25 6.1.9 Tracking of Dose and Treatment Compliance .......................................................................................... 26 6.2 Study Drug Accountability ........................................................................................................................... 26 7 Study Procedures and Schedule of Events ...................................................................................................... 26 7.1 Study Procedures/Evaluations .................................................................................................................... 26 7.1.1 Study Specific Procedures ...................................................................................................................... 27 7.2 Laboratory Procedures/Evaluations ............................................................................................................. 27 7.2.1 Clinical Laboratory Evaluations ............................................................................................................... 27 7.3 Study Schedule........................................................................................................................................... 27 7.3.1 Screening ............................................................................................................................................... 27 7.3.2 Enrollment/Baseline ..................................................................................................................... 28 7.3.3 Follow-up ................................................................................................................................................ 28 7.3.4 Final Study Visit ...................................................................................................................................... 29 7.3.5 Unscheduled Visit ................................................................................................................................... 29 7.3.6 Rescreening ........................................................................................................................................... 29 7.4 Concomitant Medications, Treatments, and Procedures .............................................................................. 29 7.4.1 Precautionary Medications, Treatments, and Procedures ........................................................................ 30 7.5 Prohibited Medications, Treatments, and Procedures .................................................................................. 30 7.6 Rescue Medications, Treatments, and Procedures................................................................................. 30 7.7 Participant Access to Study Drug at Study Center .................................................................................

View Full Text

Details

  • File Type
    pdf
  • Upload Time
    -
  • Content Languages
    English
  • Upload User
    Anonymous/Not logged-in
  • File Pages
    48 Page
  • File Size
    -

Download

Channel Download Status
Express Download Enable

Copyright

We respect the copyrights and intellectual property rights of all users. All uploaded documents are either original works of the uploader or authorized works of the rightful owners.

  • Not to be reproduced or distributed without explicit permission.
  • Not used for commercial purposes outside of approved use cases.
  • Not used to infringe on the rights of the original creators.
  • If you believe any content infringes your copyright, please contact us immediately.

Support

For help with questions, suggestions, or problems, please contact us