Sickle Cell DiseasePhase 4NCT05848531
Clonidine With Morphine in Patient Controlled Analgesia Pump in Vaso-Occlusive Crisis in Sickle Cell Disease Patient
A Phase 4 study testing Clonidine in people with Sickle Cell Disease and Vaso-occlusive Pain Episode in Sickle Cell Disease, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
Vaso-occlusive crisis are highly painful in Sickle-cell patients. Morphine is the treatment of choice for this pain. Various adjuncts have been studied for the treatment of vaso-occlusive crisis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease, Vaso-occlusive Pain Episode in Sickle Cell Disease
- What is being tested?
- Clonidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Apr 2023to 28 Feb 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Vaso-Occlusive Crisis In Sickle Cell disease Patients
Who cannot join
- Minor
- Patient's refusal
- Pregnancy
- Contr-indication Clonidine therapy
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
CHU Saint-Pierre
Brussels, 1000
Lara Chow Yuen, MD, 025353091, lara.chow@stpierre-bru.be
Andrea Carini, MD, 025354250, Andrea.carini@stpierre-bru.be
About this study
Official title: Advantage of Clonidine With Morphine In Patient Controlled Analgesia Pump for the Treatment of Vaso-occlusive Crisis in Sickle Cell Disease Patients
Vaso-occlusive crisis are highly painful in Sickle-cell patients. Morphine is the treatment of choice for this pain. Various adjuncts have been studied for the treatment of vaso-occlusive crisis.
The investigators aimed to study the effect of clonidine associated with morphine in PCIA (patient controlled intravenous analgesia pumps) regimen. The investigators will compare it to the morphine alone in PCIA for the treatment of vaso-occlusive pain.
Read more
The investigators will measure the morphine consumption of all patient, the impact on the apparition of the morphine secondary effect and on inflammation biomarkers and the biopsychosocial respond.
Each patient will be hospitalized and follow by haematologist from the hospital, pain doctors and nurses.
It will be a double blind randomised, prospective study. The randomisation will be done by the pharmacy.
- Being tested
- Clonidine
- Keywords
- Clonidine, Morphine, Acute Pain management, patient controlled analgesia
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonidineDrug
Also called Catapressan
Comparing Clonidine with Morphine PCIA for the treatment of Vaso-Occlusive crisis in Sickle Cell disease patient
| Study group | Role | What they receive |
|---|---|---|
| Morphine | No intervention | Standard Morphine PCIA |
| Clonidine and Morphine | Experimental | Morphine Associated with Clonidine PCIA Receives: Drug: Clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine Consumption
Morphine Consumption during hospitalisation
Measured: Up to two weeks
Secondary outcomes (3)
Numerical Rating Scale
Pain Score scale from 0 to ten during and after treatment
Measured: Up to two weeks
Biology markers
Inflammatory biology markers (CRP,IL-6) and Hemolysis (LDH)
Measured: Up to two weeks
Biopsychosocial model / ASCQ-ME questionary
Evaluation of the biopsychosocial model. There are seven different themes of 4 to 7 questions each (pain intensity, pain episodes, sleep impact, social impact, emotional impact, medical history and stiffness)
Measured: Up to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start25 Apr 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double Blinded, randomised, prospective
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lara Chow Yuen, Centre Hospitalier Universitaire Saint Pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848531
- Sponsor's protocol ID
- B0762023230104
- Status last verified
- Apr 2023
- First submitted
- 30 Mar 2023
- Last updated
- 8 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kenney MO, Smith WR. Moving Toward a Multimodal Analgesic Regimen for Acute Sickle Cell Pain with Non-Opioid Analgesic Adjuncts: A Narrative Review. J Pain Res. 2022 Mar 31;15:879-894. doi: 10.2147/JPR.S343069. eCollection 2022.
PubMed 35386424
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advantage of Clonidine With Morphine In Patient Controlled Analgesia Pump for the Treatment of Vaso-occlusive Crisis in Sickle Cell Disease Patients
- ClinicalTrials.gov ID
- NCT05848531
- Acronym / sponsor ID
- B0762023230104
- Keywords
- Clonidine, Morphine, Acute Pain management, patient controlled analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vaso-occlusive crisis are highly painful in Sickle-cell patients. Morphine is the treatment of choice for this pain. Various adjuncts have been studied for the treatment of vaso-occlusive crisis.
The investigators aimed to study the effect of clonidine associated with morphine in PCIA (patient controlled intravenous analgesia pumps) regimen. The investigators will compare it to the morphine alone in PCIA for the treatment of vaso-occlusive pain.
The investigators will measure the morphine consumption of all patient, the impact on the apparition of the morphine secondary effect and on inflammation biomarkers and the biopsychosocial respond.
Each patient will be hospitalized and follow by haematologist from the hospital, pain doctors and nurses.
It will be a double blind randomised, prospective study. The randomisation will be done by the pharmacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double Blinded, randomised, prospective
| Arm | Type | Receives |
|---|---|---|
| Morphine | No intervention | –Standard Morphine PCIA |
| Clonidine and Morphine | Experimental | Drug: ClonidineMorphine Associated with Clonidine PCIA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Vaso-Occlusive Crisis In Sickle Cell disease Patients
Key exclusion criteria (4 listed)
- Minor
- Patient's refusal
- Pregnancy
- Contr-indication Clonidine therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClonidineAlso: CatapressanComparing Clonidine with Morphine PCIA for the treatment of Vaso-Occlusive crisis in Sickle Cell disease patient | Drug | Clonidine and Morphine |
Primary outcome
Morphine Consumption
Time frame: Up to two weeks
Morphine Consumption during hospitalisation
3 secondary outcomes
Numerical Rating Scale
Time frame: Up to two weeks
Biology markers
Time frame: Up to two weeks
Biopsychosocial model / ASCQ-ME questionary
Time frame: Up to two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
- Background: PubMed 35386424Kenney MO, Smith WR. Moving Toward a Multimodal Analgesic Regimen for Acute Sickle Cell Pain with Non-Opioid Analgesic Adjuncts: A Narrative Review. J Pain Res. 2022 Mar 31;15:879-894. doi: 10.2147/JPR.S343069. eCollection 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clonidine in people with Sickle Cell Disease and Vaso-occlusive Pain Episode in Sickle Cell Disease, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine Consumption (time frame: Up to two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05848531, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2023.