Condition category
Haematological Disorders
Date applied
27/10/2005
Date assigned
02/02/2006
Last edited
25/01/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.anaemiaweb.org/pisces.htm

Contact information

Type

Scientific

Primary contact

Dr Adebayo Olujohungbe

ORCID ID

Contact details

Department of Haematology
Aintree University Hospital NHS Foundation Trust
Longmoor Lane
Liverpool
L9 7AL
United Kingdom
+44 (0)151 529 3375
ade.olujohungbe@aht.nwest.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

09/04

Study information

Scientific title

Acronym

PISCES

Study hypothesis

Stuttering attacks of priapism is a harbinger of a major acute attack with its poor sequelae. Penile detumesence depends on alpha adrenergic stimulation such as etilefrine, ephedrine anecdotally. We therefore want:
1. To assess if oral ephedrine or etilefrine taken by patients with sickle cell disease is tolerable and if it reduces the rates of stuttering priapism, and or major acute attacks of priapism
2. To see if oral ephedrine is comparable to etilefrine in efficacy
3. If it is so, to establish the minimum effective dose of ephedrine

Ethics approval

Ethics approval received from the West Midland Multicentre Research Ethics Committee.

Study design

Double-blind, placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information can be found at: http://www.anaemiaweb.org/Documents/Pisces/Adult%20Patient%20information.pdf

Condition

Sickle cell disease

Intervention

Oral ephedrine and oral etilefrine versus placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Etilefrine, Ephedrine

Primary outcome measures

1. A change in the frequency of attacks of stuttering priapism from baseline data
2. A change in the incidence of an acute (major) attacks of priapism

Secondary outcome measures

Tolerability of oral etilefrine (50 mg) or ephedrine at 15 mg or 30 mg with respect to side effect profile.

Overall trial start date

01/10/2005

Overall trial end date

01/10/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male patients with a documented history of sickle cell disease (SCD) irrespective of genotype (alpha thalassemia status will not be determined)
2. Patients should be 12 years or over
3. Patients with a known history of stuttering priapism (a short self limiting episode lasting up to 4 hours which tends to be recurrent) attributable to SCD
4. Patients in active attendance at a designated care centre i.e. one visit in the last six months
5. Patients on a stable dose of hydroxyurea for over six months before trial entry, provided a baseline event rate (on treatment) is established before randomisation and no dose change occurs during trial period
6. Patients who received a one-off or isolated top up transfusion greater than three months before recruitment date can be entered into study

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

320

Participant exclusion criteria

1. Patients with sickle cell trait (haemoglobin A greater than haemoglobin S on alkaline gel electrophoresis or high performance liquid chromatography (HPLC) will not be eligible for randomisation
2. Patients known to have elevated blood pressure or a history of cardiac disease
3. Patients with SCD and a documented history of stroke in the past
4. Patients with a history of acquired vessel aneurysm in the past
5. Patients known to be on MAOI (monoamine oxidase inhibitor) drugs or other drugs with significant interactions with study drugs
6. Patients known to be intolerant of adrenergic drugs
7. Patients with hyperthyroidism
8. Patients on a long-term blood transfusion programme to prevent or treat the complications of SCD

Recruitment start date

01/10/2005

Recruitment end date

01/10/2007

Locations

Countries of recruitment

Nigeria, United Kingdom

Trial participating centre

Department of Haematology
Liverpool
L9 7AL
United Kingdom

Sponsor information

Organisation

Aintree University Hospitals NHS Foundation Trust (UK)

Sponsor details

Longmoor Lane
Liverpool
Liverpool
L9 7AL
United Kingdom
+44 (0)151 529 3375
ade.olujohungbe@aht.nwest.nhs.uk

Sponsor type

Government

Website

http://www.anaemiaweb.org/pisces.htm

Funders

Funder type

Charity

Funder name

British Society of Haematology (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Aintree University Hospitals NHS Foundation Trust (UK) - small research grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

North Middlesex University Hospital NHS Trust (UK) - Haematology Research and Development grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21127308

Publication citations

  1. Results

    Olujohungbe AB, Adeyoju A, Yardumian A, Akinyanju O, Morris J, Westerdale N, Akenova Y, Kehinde MO, Anie K, Howard J, Brooks A, Davis VA, Khoriatry AI, A prospective diary study of stuttering priapism in adolescents and young men with sickle cell anemia: report of an international randomized control trial--the priapism in sickle cell study., J. Androl., 32, 4, 375-382, doi: 10.2164/jandrol.110.010934.

Additional files

Editorial Notes