Clinical Protocol RH02217 (202423)
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Clinical Protocol RH02217 (202423) Intra-oral kinetics of fluoride containing dentifrices in modified oral fluoride retention study GlaxoSmithKline Consumer Healthcare St George’s Avenue, Weybridge Surrey KT13 0DE United Kingdom 1. Protocol approval date: 25-Mar-2014 2. Final Amendment to Protocol approval date: 31-Mar-2014 Copyright: GlaxoSmithKline. This document contains confidentiality statements that are not relevant for this publicly available version Clinical Protocol RH02217 Copyright: GlaxoSmithKline. This document contains confidentiality statements that are not relevant for this publicly available version Confidential RH02217 Intra-oral kinetics of fluoride containing dentifrices in modified oral fluoride retention study GlaxoSmithKline Consumer Healthcare St George’s Avenue, Weybridge Surrey KT13 0DE United Kingdom Protocol Amendments (Record details of amendment in table below, mark the sections/pages affected “See Amendment” and attach amendment to this protocol) Number Date of Issue Section(s) & Page(s) Amended 1 2 3 4 Confidential Summary Information Title: Intra-oral kinetics of fluoride containing dentifrices in a modified oral fluoride retention study Protocol Number: RH02217 Sponsor: GlaxoSmithKline Consumer Healthcare (GSKCH) St George’s Avenue, Weybridge, Surrey, KT13 0DE, United Kingdom (UK) Protocol Author (Clinical): PPD , MSc GSKCH, St George’s Avenue, Weybridge, Surrey, KT13 0DE, UK Telephone: PPD Protocol Author PPD , MSc (Biostatistical): GSKCH, Plot No. 67, Sector 32, Gurgaon, (Haryana), India – 122001 Telephone: PPD Protocol Author (Medical): PPD , DDS, MSc GSKCH, St George’s Avenue, Weybridge, Surrey, KT13 0DE, UK Telephone: PPD Protocol Author (New PPD , MSc, PhD Product Research) GSKCH, St George’s Avenue, Weybridge, Surrey, KT13 0DE, UK Telephone: PPD 453 PRIMARY CONTACT/ Study PPD , MSc Manager: GSKCH, St George’s Avenue, Weybridge, Surrey, KT13 0DE, UK Telephone: PPD Medical Lead: PPD , PhD, MRSc GSKCH, St George’s Avenue, Weybridge, Surrey, KT13 0DE, UK Telephone: PPD Expert dental advice outside Weybridge Telephone: PPD normal office hours: Principal Investigator: Dr David Payne, BDS Study Site: Intertek Clinical Research Services (CRS) 6 Brindley Road, City Village Business Park Old Trafford, Manchester, M16 9HQ Tel: PPD Product Name: Dentifrice containing 5% potassium nitrate (KNO3) and 1450parts per million (ppm) fluoride as sodium fluoride (NaF) (Sensodyne® Pronamel® Daily Protection) Dentifrice containing 5% KNO3 and 1450ppm fluoride as NaF (Colgate® Sensitive Enamel Protect) IND/EUDRACT No: N/A Phase of study: Exploratory ® Sensodyne is a registered trademark of GlaxoSmithKline Consumer Healthcare, LP. ® Pronamel is a registered trademark of GlaxoSmithKline Consumer Healthcare, LP. ® Colgate is a registered trademark of Colgate-Palmolive. Protocol Agreement Intra-oral kinetics of fluoride containing dentifrices in a modified oral fluoride retention study RH02217 The signature of the investigator below constitutes his/her approval of this protocol and provides the necessary assurances that this study will be conducted according to Good Clinical Practice [ICH 1996] and to all stipulations, clinically and administratively, as stated in the protocol, including all statements as to confidentiality. It is agreed that the conduct and results of this study will be kept confidential and that the case report forms and other pertinent data will become the property of GlaxoSmithKline Consumer Healthcare (GSKCH). It is agreed that the protocol contains all necessary information required to conduct the study and that the study will not be initiated without the approval of an appropriate Independent Ethics Committee (IEC) It is agreed that all participants in this study will provide written informed consent in accordance with the requirements specified in the Declaration of Helsinki [World Medical Association Declaration of Helsinki, 59th General Assembly, Seoul 2008]. All participants will also be informed that their medical records will be kept confidential except for review by representatives of GSKCH and/or appropriate IEC representatives and regulatory authorities. In some instances, a summary of the protocol and study results, along with the names of the principal investigator from each study site, and details of the institutions with which the investigator is affiliated will be posted in one or more publicly accessible worldwide registers at any time after the commencement of the study. The signature of the investigator below constitutes his consent to have his name and institution disclosed should this study be made publicly available on a register. In addition, in order to avoid confusing or conflicting information, the signature of the investigator below constitutes his agreement not to post information about the study on any clinical trials registry without first obtaining the prior written consent of GSK. Dr David Payne, BDS PPD PPD Principal Investigator Signature Date Table of Contents Summary Information ........................................................... 3 Protocol Agreement................................................................ 5 Study Synopsis........................................................................ 9 List of Abbreviations.............................................................. 15 Study Schedule........................................................................ 16 1 Introduction................................................................... 17 2 Exploratory Objectives................................................. 18 3 Investigational Plan....................................................... 19 3.1 Study Design..................................................................19 3.2 Rationale for Study Design...........................................22 4 Study Population........................................................... 23 4.1 Source and Number of Subjects...................................23 4.2 Inclusion Criteria..........................................................23 4.3 Exclusion Criteria .........................................................24 4.4 Subject Withdrawal Criteria........................................25 4.5 Subject Replacement ....................................................26 4.6 Subject Restrictions ......................................................26 4.6.1 Lifestyle...........................................................................26 4.6.2 Medications and treatments..............................................27 5 Study Products, Assignment, and Supply Management ........................................................................................ 27 5.1 Study Products..............................................................27 5.1.1 Identity of study products.................................................27 5.1.2 Selection of doses ............................................................28 5.1.3 Administration .................................................................28 5.1.4 Dose schedule ..................................................................29 5.1.5 Dose modification............................................................29 5.1.6 Product compliance..........................................................29 5.1.7 Precautions.......................................................................29 5.1.8 Overdosage ......................................................................29 5.2 Study Product Assignment ...........................................30 5.2.1 Randomisation procedure.................................................30 5.2.2 Blinding procedure and code breaks.................................30 5.3 Study Product Supplies Management..........................31 5.3.1 Packaging and labelling ...................................................31 5.3.2 Accountability of study supplies ......................................31 5.3.3 Storage of study product supplies.....................................32 6 Study Schedule .............................................................. 32 7 Screening and Baseline Methods, Measurements and Evaluations and Study Conclusion .............................. 32 7.1 Screening .......................................................................32 7.1.1 Informed consent .............................................................32 7.1.2 Demographics ..................................................................33 7.1.3 Medical history ................................................................33 7.1.4 Full Oral soft tissue examination......................................33 7.1.5 Salivary flow rates ...........................................................33 7.1.6 Study Conclusion.............................................................34 8 Outcome Measurements and Evaluations ................... 34 8.1 Saliva Sample Collection Procedure ............................34 8.2 Sample Analysis ............................................................35 9 Safety Measurements and Evaluations........................ 35 9.1 Adverse Events and Serious Adverse Events ..............35 9.1.1 Definitions .......................................................................35 9.1.2 Reporting adverse events and serious adverse events .......38 9.1.3 Adverse event grading and assessments ...........................41 9.2 Pregnancy......................................................................42 9.2.1 Time period for collecting pregnancy information............42 9.2.2