SchizophreniaPhase 3NCT00843687
A Comparison of the Pharmacokinetics and Safety of Long-acting Injectable Risperidone When Administered to Gluteal or Deltoid Intramuscular Injection Sites in Stable Schizophrenia Patients.
A Phase 3 study testing Risperidone long-acting injectable in people with Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to compare the pharmacokinetics and safety of long-acting injectable risperidone, an atypical antipsychotic medication used for the treatment of patients with schizophrenia, when it is administered as an intramuscular injection via the deltoid muscle, compared with intramuscular injection… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Risperidone long-acting injectable
- Type of treatment
- Injection or infusion
- How many people
- 188 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Mar 2007
- Phase
- Phase 3
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic schizophrenia of any subtype, according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria
- stable schizophrenia without any changes in medications or dosage during the 4 weeks before the screening visit
- Clinical Global Impression scale score of <=3 (mild)
- informed consent signed by the patient
- patient is otherwise healthy on the basis of a prestudy physical examination and medical history.
Who cannot join
- No DSM-IV Axis I diagnosis other than schizophrenia
- no pregnant or breast feeding women
- no female subject of childbearing potential without adequate contraception
- no history of severe drug allergy or hypersensitivity
- no patients with inadequate mass in the gluteal or deltoid regions to receive the intramuscular drug injections.
About this study
Official title: Comparative Single-Dose Pharmacokinetics and Safety of Gluteal and Deltoid Intramuscular Injection of Long-Acting Injectable Risperidone in Subjects With Chronic Stable Schizophrenia
The purpose of this study is to compare the pharmacokinetics and safety of long-acting injectable risperidone, an atypical antipsychotic medication used for the treatment of patients with schizophrenia, when it is administered as an intramuscular injection via the deltoid muscle, compared with intramuscular injection via the gluteal muscle.
Read the detailed description
This is a randomized, open label, single dose, multicenter, 2-way crossover study comprising a screening phase, 2 open-label treatment periods, and end-of-study evaluations. The study population will comprise patients with chronic stable schizophrenia. Patients will be allowed to continue on their existing oral antipsychotic treatment throughout the study, if not receiving disallowed mediations, per protocol. Patients will be randomly allocated to receive treatment in 1 of 2 panels. In each panel, patients will receive a single intramuscular injection of long-acting injectable risperidone in each treatment period, in a 2-way crossover design. In Panel I, patients will receive 25 mg long-acting injectable risperidone via the gluteal muscle and 37.5 mg long-acting injectable risperidone via the deltoid muscle during the study period. In Panel II, patients will receive 50 mg long-acting injectable risperidone via the gluteal muscle and 50 mg long-acting injectable risperidone via the deltoid muscle. There will be a washout period of 85 days between each administration of study drug. The primary outcome will be comparison of the pharmacokinetic parameters area under the curve (AUC) and peak plasma concentration (Cmax) for 37.5 mg deltoid versus 25 mg gluteal, and for 50 mg deltoid versus 50 mg gluteal. Safety will be assessed at screening, throughout the open-label treatment phase, and at the end of study or early withdrawal using a combination of adverse events (including occurrence of extrapyramidal symptoms as assessed by the Extrapyramidal Symptoms Rating Scale), clinical laboratory tests (hematology, serum chemistry, urinalysis, and pregnancy testing), vital signs, physical examinations, electrocardiograms, and injection site evaluation. The study hypothesis is that intramuscular injections of long-acting injectable risperidone via the gluteal and deltoid sites will be bioequivalent routes of administration, as measured by peak and total drug concentrations in the plasma, and that the safety and tolerability profiles of the 2 injection sites will be comparable. The patients will receive a single injection of long--acting injectable risperidone (25 mg, 37.5 mg or 50 mg) in their gluteal or deltoid muscle in 2 treatment periods.
- Conditions
- Schizophrenia
- Being tested
- Risperidone long-acting injectable
- Keywords
- Schizophrenia, Risperidone, Long-acting injectable, Intramuscular injection, Pharmacokinetics
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risperidone long-acting injectableDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the pharmacokinetic parameters AUC and Cmax for 37.5 mg deltoid versus 25 mg gluteal, and for 50 mg deltoid versus 50 mg gluteal based on blood sampling at predefined intervals up to 85 days.
Secondary outcomes (1)
Patient-rated local site injection pain (measured on a visual analogue scale) & investigator-rated local site injection reaction (measured by injection site evaluation scale) measured 30 min. before injection & at regular intervals up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startSep 2005
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843687
- Sponsor's protocol ID
- CR011023
- Status last verified
- Jun 2011
- First submitted
- 12 Feb 2009
- Last updated
- 9 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Single-Dose Pharmacokinetics and Safety of Gluteal and Deltoid Intramuscular Injection of Long-Acting Injectable Risperidone in Subjects With Chronic Stable Schizophrenia
- ClinicalTrials.gov ID
- NCT00843687
- Acronym / sponsor ID
- CR011023
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Risperidone, Long-acting injectable, Intramuscular injection, Pharmacokinetics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 13 Feb 2009 (estimated)
- 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.
The purpose of this study is to compare the pharmacokinetics and safety of long-acting injectable risperidone, an atypical antipsychotic medication used for the treatment of patients with schizophrenia, when it is administered as an intramuscular injection via the deltoid muscle, compared with intramuscular injection via the gluteal muscle.
Detailed description
This is a randomized, open label, single dose, multicenter, 2-way crossover study comprising a screening phase, 2 open-label treatment periods, and end-of-study evaluations. The study population will comprise patients with chronic stable schizophrenia. Patients will be allowed to continue on their existing oral antipsychotic treatment throughout the study, if not receiving disallowed mediations, per protocol. Patients will be randomly allocated to receive treatment in 1 of 2 panels. In each panel, patients will receive a single intramuscular injection of long-acting injectable risperidone in each treatment period, in a 2-way crossover design. In Panel I, patients will receive 25 mg long-acting injectable risperidone via the gluteal muscle and 37.5 mg long-acting injectable risperidone via the deltoid muscle during the study period. In Panel II, patients will receive 50 mg long-acting injectable risperidone via the gluteal muscle and 50 mg long-acting injectable risperidone via the deltoid muscle. There will be a washout period of 85 days between each administration of study drug. The primary outcome will be comparison of the pharmacokinetic parameters area under the curve (AUC) and peak plasma concentration (Cmax) for 37.5 mg deltoid versus 25 mg gluteal, and for 50 mg deltoid versus 50 mg gluteal. Safety will be assessed at screening, throughout the open-label treatment phase, and at the end of study or early withdrawal using a combination of adverse events (including occurrence of extrapyramidal symptoms as assessed by the Extrapyramidal Symptoms Rating Scale), clinical laboratory tests (hematology, serum chemistry, urinalysis, and pregnancy testing), vital signs, physical examinations, electrocardiograms, and injection site evaluation. The study hypothesis is that intramuscular injections of long-acting injectable risperidone via the gluteal and deltoid sites will be bioequivalent routes of administration, as measured by peak and total drug concentrations in the plasma, and that the safety and tolerability profiles of the 2 injection sites will be comparable. The patients will receive a single injection of long--acting injectable risperidone (25 mg, 37.5 mg or 50 mg) in their gluteal or deltoid muscle in 2 treatment periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Chronic schizophrenia of any subtype, according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria
- stable schizophrenia without any changes in medications or dosage during the 4 weeks before the screening visit
- Clinical Global Impression scale score of <=3 (mild)
- informed consent signed by the patient
- patient is otherwise healthy on the basis of a prestudy physical examination and medical history.
Key exclusion criteria (5 listed)
- No DSM-IV Axis I diagnosis other than schizophrenia
- no pregnant or breast feeding women
- no female subject of childbearing potential without adequate contraception
- no history of severe drug allergy or hypersensitivity
- no patients with inadequate mass in the gluteal or deltoid regions to receive the intramuscular drug injections.
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 |
|---|---|---|
| Risperidone long-acting injectable | Drug | – |
Primary outcome
Comparison of the pharmacokinetic parameters AUC and Cmax for 37.5 mg deltoid versus 25 mg gluteal, and for 50 mg deltoid versus 50 mg gluteal based on blood sampling at predefined intervals up to 85 days.
1 secondary outcome
Patient-rated local site injection pain (measured on a visual analogue scale) & investigator-rated local site injection reaction (measured by injection site evaluation scale) measured 30 min. before injection & at regular intervals up to Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2011.
- A comparison of the pharmacokinetics and safety of long-acting injectable risperidone when administered to gluteal or deltoid intramuscular injection sites in stable schizophrenia patients.Link provided by the sponsor.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Risperidone long-acting injectable in people with Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 9 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the pharmacokinetic parameters AUC and Cmax for 37.5 mg deltoid versus 25 mg gluteal, and for 50 mg deltoid versus 50 mg gluteal based on blood sampling at predefined intervals up to 85 days.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2011.