Clinical Trials Register

Summary
EudraCT Number:	2013-003327-11
Sponsor's Protocol Code Number:	3623
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-12-17
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

UK - MHRA

A.2

EudraCT number

2013-003327-11

A.3

Full title of the trial

Alternative Treatments of Adult female Urinary Tract Infection: a double blind, placebo controlled,factorial randomised trial of Uva ursi and open pragmatic trial of ibuprofen.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

ATAFUTI - A Trial Investigating Alternative Treatments of Adult Female Urinary Tract Infection.

A.3.2

Name or abbreviated title of the trial where available

ATAFUTI

A.4.1

Sponsor's protocol code number

3623

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

ISRCTN43397016

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	University of Southampton
B.1.3.4	Country	United Kingdom
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	NIHR School for Primary Care Research
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Southampton, Clinical Trials Unit
B.5.2	Functional name of contact point	ATAFUTI Trials Manager
B.5.3	Address:
B.5.3.1	Street Address	MP 131, Southampton General Hospital, Tremona Road
B.5.3.2	Town/ city	Southampton
B.5.3.3	Post code	SO16 6YD
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	023812035171
B.5.5	Fax number	08447740621
B.5.6	E-mail	catherine.simpson@soton.ac.uk

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	ARCTUVAN
D.2.1.1.2	Name of the Marketing Authorisation holder	Temmler Werke GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Uva ursi
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Arbutin
D.3.9.1	CAS number	497-76-7
D.3.9.3	Other descriptive name	hydroquinone-β-D-monoglucopyranoside
D.3.9.4	EV Substance Code	AS1
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	76.13
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	Yes
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Acute urinary tract infections.

E.1.1.1

Medical condition in easily understood language

Acute urinary tract infections

E.1.1.2

Therapeutic area

Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	LLT
E.1.2	Classification code	10000698
E.1.2	Term	Acute cystitis
E.1.2	System Organ Class	100000004862

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate whether Uva ursi compared to placebo or the advice to take ibuprofen compared to no advice provide relief from urinary symptoms in adult women with suspected UTI.

E.2.2

Secondary objectives of the trial

To evaluate whether Uva ursi compared to placebo or the advice to take ibuprofen compared to no advice result in reduced antibiotic use in adult women with suspected UTI.

To determine the patient/practitioner barriers to implementation of a delayed antibiotic prescription approach and the use of herbal medication.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Adult women (18-70) presenting to primary care with suspected lower urinary tract infection i.e. with at least one of dysuria, urgency or frequency.
• Patient able to provide informed written consent.
• Women willing to accept a delayed prescription for antibiotics.

E.4

Principal exclusion criteria

• Known or suspected pregnancy or breast feeding
In women of child bearing age a urine pregnancy test will usually be performed unless not indicated (for instance prior hysterectomy)
• Known immunodeficiency state, long term corticosteroids therapy or chemotherapy
• Diabetes
• Has any of the following (A – F) known contra-indications or cautions to Ibuprofen and any as listed in the current SmPC:
A. Asthmatics sensitive to NSAIDS/ Ibuprofen or Aspirin
B. Severe heart failure and uncontrolled hypertension
C. Active gastro-intestinal ulceration or bleeding
D. Crohn’s disease or ulcerative colitis
E. Documented poor renal function
F. Chronic Kidney disease (Grade 3 - 5)
• Currently or within 7 days taken antibiotics
• Using a NSAID or Uva Ursi preparation and unwilling to discontinue for the study period
• Suspected upper urinary tract infection (back pain, high fever>38C, systemic illness)
• Women whom immediate antibiotics are otherwise indicated - frequent recurrent infection: >3 UTI episodes in past 12 months
• Defect of the blood clotting system
• Bladder surgery including cystoscopy in the last four weeks.
• Currently taking Warfarin
• Recruited to another interventional randomised control trial in previous 4 weeks.

E.5 End points

E.5.1

Primary end point(s)

Symptom severity at day 2-4 recorded in a validated self report diary.

E.5.1.1

Timepoint(s) of evaluation of this end point

At day 2 -4.

E.5.2

Secondary end point(s)

Use of antibiotics.
Duration of moderately bad symptoms.
Reconsultation in one and three months with UTI.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

2 x 2 factorial design

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Patients notes review will be completed 3 months after the last patient is randomised into the trial to assess how many return visits have been made to the GP with Urinary Tract Infections.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1