Sie sind auf Seite 1von 4

Acest material este proprietatea Disciplinei Controlul Medicamentului și se supune reglementărilor în vigoare

privind copywrite-ul. Anumite informații precum și modul de prezentare sunt parte a Acordului de Confidențialitate
dat de către participanții la cursul optional „ Evaluarea documentației pentru studii clinice”.

GeoFarmaMed CRO

MINISTRY OF HEALTH 12345C / 08.03.2016


National Agency for Medicines and Medical Devices
48 Av Sanatescu, sector 1
011478, Bucharest

01 March 2016

Product Name: GTAB-01


EudraCT No.: 2015-436743-08
Sponsor Protocol No: GTAB-01-2016
Title: A Phase III Randomised, Double-Blind, Placebo-controlled,
Multi-centre Study to Evaluate the Efficacy and Safety for
GTAB-01 capsules in Adults with Pain
Sponsor: Controlul Medicamentului, Republic of Moldavia Dep.
Sponsor EU Representative: Controlul Medicamentului, Romania Dep.
NAMMD Reference: 12345/01.02.2016

RE: REQUEST FOR AUTHORISATION OF A CLINICAL TRIAL ON A


MEDICINAL PRODUCT FOR HUMAN USE TO THE COMPETENT AUTHORITY

Dear Mr. President,

On behalf of the Sponsor, Controlul Medicamentului, Dep., please find enclosed a complete
Clinical Trial Application with supporting documentation (checklist attached) for Controlul
Medicamentului Study GTAB-01-2016.

The proposed Phase 3 study, GTAB-01-2016, is a randomized, double-blind, placebo-controlled,


multi-centre study to evaluate the efficacy and safety for GTAB-01 capsules for the treatment of
adults subjects with pain.

Approximately 300 subjects will be randomized in a 1:1 ratio to one of the two treatment arms
(A: B) for 5 day dosing for a total of 20 doses. All subjects will be treated with AAS 500 mg
oral twice per day for 10 days.

Treatment Arm A: 150 subjects administered AAS 500 mg oral twice daily + GTAB-01 orally
4 times on day for 5 days.
Treatment Arm B: 150 subjects administered AAS 500 mg oral twice daily + GTAB-01
placebo to match orally 4 times on day for 5 days.

After 5 days, GTAB-01 will be discontinued. All subjects will continue receiving AAS and
placebo for next 5 days.

1
Acest material este proprietatea Disciplinei Controlul Medicamentului și se supune reglementărilor în vigoare
privind copywrite-ul. Anumite informații precum și modul de prezentare sunt parte a Acordului de Confidențialitate
dat de către participanții la cursul optional „ Evaluarea documentației pentru studii clinice”.

GeoFarmaMed CRO

The primary objectives of this study are as follows:


 To evaluate the efficacy of GTAB-01 in adult subjects with pain as add-on to AAS
 To evaluate the safety of GTAB-01 in adult subjects with pain

Treatment will be supplied as packs with 25 soft capsules with GTAB-01 or Placebo GTAB-01
and 20 AAS tablets for first period of 5 days and packs with 25 soft capsules with Placebo
GTAB-01 and 20 AAS tablets for the next period of 5 days.

Reviewers notes:
Protocol: It is noted that the GTAB-01-2016 protocol has been labelled as Version 1.0
(Original), dated 01-Dec-2015. This is a complete protocol (including the original protocol)
containing all the relevant information on the design of this study.
Scientific Advice: No Scientific Advice has been obtained on GTAB-01.
PIP: This CTA does not form part of the GTAB-01 PIP (PDCO adopted 10 October 2015).
The IB is submitted as the reference safety information for both GTAB-01 and AAS (SmPC).

Should you have any questions regarding this submission please do not hesitate to contact the
undersigned.

Yours faithfully,

Ion Nelu Ionescu,


Regulatory Affairs Associate

GeoFarmaMed CRO ROMANIA SRL


(On Behalf of Controlul Medicamentului, Republic of Moldavia Dep.)
Phone : 0040 744111111
Fax : 0040 21 6111111
Email: ion_nelu_ionescu@geofarmamed.com

List of Documents included in this submission is including on the CD-ROM:


EudraCT Number: 2015-002017-30

I. General
01. Cover Letter, dated 01 March 2016
02. Receipt of confirmation of EudraCT Number, 15 February 2016
03. List of EU Competent Authorities involved in the trial, dated September
2015
04a. Signed EudraCT Application Form (PDF), 15 February 2015
04b. EudraCT Application Form (xml file), 15 February 2015
04c. EudraCT Validation Report, 15 February 2015

2
Acest material este proprietatea Disciplinei Controlul Medicamentului și se supune reglementărilor în vigoare
privind copywrite-ul. Anumite informații precum și modul de prezentare sunt parte a Acordului de Confidențialitate
dat de către participanții la cursul optional „ Evaluarea documentației pentru studii clinice”.

GeoFarmaMed CRO

05. Sponsor’s legal representative authorization, 10 February 2015


06. Letter of Delegation for the Applicant, 10 February 2015

II. Protocol Related


01. Protocol GTAB-01-2016, Version 1.0 (Original), 01-Dec-2015
02a. Principal Investigator Signature Page: Dr. George Georgescu, 01 February
2016
02b. Principal Investigator Signature Page: Dr. Calin Calinescu, 01 February
2016
03. Protocol Synopsis – protocol GTAB-01-2016, in Romanian, Version 1.0
(Original), 01-Dec-2015

III. Investigator’s Brochure


01. GTAB-01 Investigator’s Brochure, Edition 1, 12 January 2016
02. AAS Prospect

IV. IMPD
01. GTAB-01 IMPD, Version 1, dated 10 January 2016
02. AAS SmPC
03a. Label GTAB-01 or Placebo GTAB-01 soft capsules, 500 mg, dated 01
March 2016
03b. Label Paracetamol or Placebo Paracetamol tablets, 500 mg, dated 01 March
2016
03c. Label AAS tablets, 500 mg, dated 01 March 2016
04. Outline of active trials with GTAB-01, dated Sep 2015
05. QP Declaration for GTAB-01 soft capsules and placebo to match GTAB-01
soft capsules – Controlul Medicamentului, Romania Dep.
06. Importers Manufacturing Authorisation – Controlul Medicamentului,
Romania Dep., 26 August 2014
07a. Certificate of Analysis – Placebo GTAB-01 soft capsules, 500 mg, Feb 2015
07b. Certificate of Analysis – GTAB-01 soft capsules, 500 mg, Feb 2015

V. Facilities and Staff related

V.1 S.C. GGG SRL / PI: PhD. Dr. George Gheorghe Georgescu
01. Authorization for Clinical Trial of the site: S.C. GGG SRL / PI: George
Gheorghe Georgescu, dated 01 November 2015
02. Hospital Manager Approval of site: S.C. GGG SRL / PI: George Gheorghe
Georgescu, dated 02 December 2015
03a. CV for PI: Dr. George Gheorghe Georgescu, dated 07 November 2015
03b. CV for sub-I: Dr. Maria Marinescu, dated 07 November 2015
04. Specialist Confirmation Certificate: Dr. George Gheorghe Georgescu, Ord.
OMS no. 123, dated 18 February 2007
05. Investigator qualification Form of Dr. George Gheorghe Georgescu, dated
22 October 2015
06a. Certificate of Completion GCP training for PI: Dr. George Gheorghe

3
Acest material este proprietatea Disciplinei Controlul Medicamentului și se supune reglementărilor în vigoare
privind copywrite-ul. Anumite informații precum și modul de prezentare sunt parte a Acordului de Confidențialitate
dat de către participanții la cursul optional „ Evaluarea documentației pentru studii clinice”.

GeoFarmaMed CRO

Georgescu, dated 11 February 2013


06b. Certificate of Completion GCP training for sub-I: Dr. Maria Marinescu,
dated 11 February 2013
V.2 S.C. CC SRL / PI: Dr. Calin Calinescu
01. Authorization for Clinical Trial of the site: S.C. CC SRL / PI: Dr. Calin
Calinescu, dated 27 November 2015
02. Hospital Manager Approval of site: S.C. CC SRL / PI: Dr. Calin
Calinescu, dated 23 October 2015
03a. CV for PI: Dr. Calin Calinescu, dated 07 November 2014
03b. CV for sub-I: Dr. Paula Paulescu, dated 07 November 2014
04. Specialist Confirmation Certificate: Dr. Calin Calinescu, Ord. OMS no.
456, dated 02 June 2008
05. Investigator qualification Form of Dr. Calin Calinescu, dated 23 October
2015
06a. Certificate of Completion GCP training for PI: Dr. Calin Calinescu, dated
04 April 2014
06b. Certificate of Completion GCP training for sub-I: Dr. Paula Paulescu, dated
04 April 2014

VI. Confirmation of payment


01. Confirmation of payment no. 12345, received on 15 January 2016

VII. Additional documents


01. BSE/TSE Statement