A randomised double blind controlled trial of oral ephedrine/etilefrine in the prevention of recurrent (stuttering) attacks of priapism in sickle cell disease: a multicentre international study in older children and adults
| ISRCTN | ISRCTN54312363 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54312363 |
| Secondary identifying numbers | 09/04 |
- Submission date
- 27/10/2005
- Registration date
- 02/02/2006
- Last edited
- 25/01/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Adebayo Olujohungbe
Scientific
Scientific
Department of Haematology
Aintree University Hospital NHS Foundation Trust
Longmoor Lane
Liverpool
L9 7AL
United Kingdom
| Phone | +44 (0)151 529 3375 |
|---|---|
| ade.olujohungbe@aht.nwest.nhs.uk |
Study information
| Study design | Double-blind, placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at: http://www.anaemiaweb.org/Documents/Pisces/Adult%20Patient%20information.pdf |
| Scientific title | |
| Study acronym | PISCES |
| Study objectives | 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(s) | Ethics approval received from the West Midland Multicentre Research Ethics Committee. |
| Health condition(s) or problem(s) studied | Sickle cell disease |
| Intervention | Oral ephedrine and oral etilefrine versus placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Etilefrine, Ephedrine |
| Primary outcome measure | 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 study start date | 01/10/2005 |
| Completion date | 01/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 320 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 01/10/2007 |
Locations
Countries of recruitment
- England
- Nigeria
- United Kingdom
Study participating centre
Department of Haematology
Liverpool
L9 7AL
United Kingdom
L9 7AL
United Kingdom
Sponsor information
Aintree University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Longmoor Lane
Liverpool
Liverpool
L9 7AL
England
United Kingdom
| Phone | +44 (0)151 529 3375 |
|---|---|
| ade.olujohungbe@aht.nwest.nhs.uk | |
| Website | http://www.anaemiaweb.org/pisces.htm |
"ROR" |
https://ror.org/02h67vt10 |
Funders
Funder type
Charity
British Society of Haematology (UK)
No information available
Aintree University Hospitals NHS Foundation Trust (UK) - small research grant
No information available
North Middlesex University Hospital NHS Trust (UK) - Haematology Research and Development grant
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2010 | Yes | No |
