Clinical Trials Register

Summary
EudraCT Number:	2013-003867-76
Sponsor's Protocol Code Number:	RRK4249
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2013-09-26
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

2013-003867-76

A.3

Full title of the trial

A prospective, randomised controlled trial to determine the safety and efficacy of steroid impregnated tape compared to standard therapy with silver nitrate in the treatment of over-granulating peritoneal dialysis catheter exit sites

A.3.1

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

A randomised, controlled trial to compare the safety and effectiveness of steroid tape with silver nitrate therapy, the current standard treatment for patients who have over-granulating tissue of their periotoneal dialysis catheter exit site.

A.3.2

Name or abbreviated title of the trial where available

Steroid tape to treat overgranulating PD exit sites

A.4.1

Sponsor's protocol code number

RRK4249

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 Hospitals Birmingham NHS Foundation Trust
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	National Institute for Health Research, Research for Patient Benefit Programme
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	University Hospitals Birmingham NHS Foundation Trust
B.5.2	Functional name of contact point	Nicola Anderson
B.5.3	Address:
B.5.3.1	Street Address	Room 22,Clinical Research Offices, Old Queen Elizabeth Hospital, QEMC, Edgbaston
B.5.3.2	Town/ city	Birmingham
B.5.3.3	Post code	B15 2TH
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	07769648885
B.5.5	Fax number	01216272880
B.5.6	E-mail	nicola.anderson@uhb.nhs.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	Haelan Tape
D.2.1.1.2	Name of the Marketing Authorisation holder	Typharm Limited
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	NA
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Medicated plaster
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Fludroxycortide
D.3.9.3	Other descriptive name	flurandrenolone
D.3.9.4	EV Substance Code	AS2
D.3.10	Strength
D.3.10.1	Concentration unit	µg/m2 microgram(s)/square meter
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
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	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	Avoca Caustic Applicator 95% w/w Cutaneous Stick
D.2.1.1.2	Name of the Marketing Authorisation holder	Bray Group Ltd
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	NA
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Cutaneous stick
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Silver nitrate
D.3.9.4	EV Substance Code	AS1
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/W) percent weight/weight
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	95
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
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	No
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Over-granulation of peritoneal dialysis exit site in patients with End Stage Renal Failure

E.1.1.1

Medical condition in easily understood language

Peritoneal dialysis involves the draining in and out of dialysis fluid via a tube into the abdomen. Sometimes the skin around this tube becomes, red, sore and stands proud. This can lead to infection.

E.1.1.2

Therapeutic area

Body processes [G] - Biological Phenomena [G16]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	PT
E.1.2	Classification code	10034660
E.1.2	Term	Peritoneal dialysis
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10008831
E.1.2	Term	Chronic ambulatory peritoneal dialysis
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10067974
E.1.2	Term	Automated peritoneal dialysis
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	PT
E.1.2	Classification code	10067594
E.1.2	Term	Peritoneal dialysis complication
E.1.2	System Organ Class	10022117 - Injury, poisoning and procedural complications

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10064116
E.1.2	Term	Continuous ambulatory peritoneal dialysis
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

A complication of peritoneal dialysis can be over-granulation of the tissue surrounding the point where the peritoneal dialysis catheter exits the abdomen. This over-granulation tissue appears red, bumpy and inflamed. This tissue is often also painful and can easily become infected.
The principal research objective of this study is to assess the total response at 14 days to treatment with either steroid impregnated tape (Haelan tape) or silver nitrate therapy on the over-granulated tissue.

E.2.2

Secondary objectives of the trial

The secondary research questions/objectives of this study are:
1) If the treatment has not completely resolved the over-granulation, leaving the tissue surrounding the exit site healthy, what is the partial response to the treatment the patient received. The partial response to treatment will be assessed at Day 14 and Day 28.
2) Following treatment, what is the rate of recurrence of over-granulation tissue at Days 28 and Day 56 of the study.
3) Following treatment, what is the rate of exit site infections within 28 & 56 days. (An Exit site infection is defined as occurring when a clinician decides treatment with antibiotics is required)
4)Exit site swab results. At defined time-points the exit site will be swabbed by trained staff to detect the presence of micro-organisms
5) The study will also assess patient reported pain and discomfort, as well as satisfaction, in terms of convenience and ease of use, with the treatment they received to treat their over-granulation tissue.
6)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Inclusion criteria;

• Subject has been established on Peritoneal Dialysis for > 3 months
• Subject has an over-granulating exit site judged to require treatment according to standard
• If patient has exit site infection, they must currently be treated with antibiotics and the site must be clinically improving.
• Subject is > 18 years of age
• Subject is able to give informed consent

E.4

Principal exclusion criteria

Exclusion criteria;

• Subject has had peritonitis treated in the previous month
• Subject has been treated with silver nitrate or topical steroids in the previous 2 weeks
• Subject is receiving oral steroids
• Patient is unable to give informed consent
• Patient is participating in a clinical trial of an intervention relating to PD catheters.
• Subject is pregnant or unwilling to use an effective method of contraception during the course of the study

E.5 End points

E.5.1

Primary end point(s)

E.5.1.1

Timepoint(s) of evaluation of this end point

The primary endpoint will be complete response rate in over-granulation severity at 14 days, as assessed by inspection of sequential photographs of the exit site by two independent observers blinded to designated randomised treatment arm.

E.5.2

Secondary end point(s)

Secondary endpoints will be:
1. Partial response rate of over-granulation to treatment
2. Recurrence of over-granulation
3. Exit site infections
4. Exit site swab results
5. Patient reported pain, discomfort and satisfaction score
6. Occurrence of redness, ulceration or infection using a standardised exit site assessment tool

E.5.2.1

Timepoint(s) of evaluation of this end point

Secondary endpoints will be evaluated at the following time points:
1. Partial response rate of over-granulation to treatment at 14 and 28 days
2. Recurrence of over-granulation within 28 and 56 days
3. Exit site infections within 28 and 56 days
4. Exit site swab results following swabs taken at day 0, 7, 14, 21, 28 and 56
5. Patient reported pain, discomfort and satisfaction score at visits at day 0, 7, 14, 21, 28 and 56
6. Occurrence of redness, ulceration or infection using a standardised exit site assessment tool at visits at day 0, 7, 14, 21, 28 and 56

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

Yes

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

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

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

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

The trial will end when the last patient has completed 56 days of follow up

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1