A study to evaluate the effect of ticagrelor in reducing the number of days with pain in patients with sickle cell disease.
- Conditions
- Investigating the number of days of pain in SCD patients.Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2014-005420-10-GB
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 87
1. Male and female young adults aged = 18 to = 30 years inclusive, diagnosed with homozygous sickle cell (HbSS) or sickle beta-zero-thalassaemia (HbS/ß0).
2. If treated with an anti-sickling agent such as hydroxyurea, dose must be stable for 3 months before enrolment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Patients should have low risk for haemorrhagic events, no significant hepatic impairment or renal failure requiring dialysis and low risk of bradycardic events.
2. No concomitant oral or intravenous therapy with strong CYP3A4 (cytochrome) inhibitors, CYP3A4 substrates with narrow therapeutic indices, or strong CYP3A4 inducers.
3. No surgical procedure planned to occur during the study.
4. Patients who are currently pregnant or breastfeeding or planning to become pregnant during the study.
5. Patients who have known hypersensitivity or contraindication to ticagrelor.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The effectiveness of two different doses of ticagrelor versus placebo in reducing the number of days with pain due to sickle cell disease.;<br> Secondary Objective: The effectiveness of two different doses of ticagrelor versus placebo in reducing the intensity of pain due to sickle cell disease.<br> The effectiveness of two different doses of ticagrelor versus placebo in reducing the use of analgesics due to sickle cell disease.<br> ;Primary end point(s): Number of days with pain due to sickle cell disease.;Timepoint(s) of evaluation of this end point: Baseline to end of treatment (16 weeks).
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Intensity of pain due to sickle cell disease and days of analgesic use.;Timepoint(s) of evaluation of this end point: Baseline to end of treatment (16 weeks).