CancerPhase 3NCT00224692
Analgesic Effect in Children of Low-Dose Ketamine for Mucositis Treated by Patient-Controlled Analgesia With Morphine
A Phase 3 study testing Low dose ketamine in people with Cancer and Mucositis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Hypothesis : Low dose ketamine has an analgesic effect in children with mucositis treated by patient-controlled analgesia with morphine Read more about this study
- Who is it for?
- Ages 5 to 18 years
- What is being tested?
- Low dose ketamine
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2003to Aug 2006
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Painful mucositis
- Child from 5 to 18 years.
- Presenting mucitis induced by chemotherapy or a conditioning of graft hematopoïetic.
- A pain not controlled by systematic paracetamol (10mg/kg/4h) or a the propacetamol (20mg/kg/4h).
- Not presenting a neurological or psychological difficulty at the use of the PCA or a EVA.
- First morphine amount going back to less 48h, and lass administration dating of more than 4h at the time of the beginning of the perfusion of Ketamine/placebo (EVA > 30 after stop morphine).
- Assent signed by the parents and each time possible by the child.
Who cannot join
- The child was already included in the study.
- The age of psychomotor development is lower than 5 years
- Presence of a depression or a major depressive episode according to definition DSM IV.
- Hepatic or renal anomaly major (rank 3 or 4 of the scale of toxicity NCI CTC v2.0)
- Bilirubin>3N
- Gamma WP>3N
- SGOT or SGPT >5N
- Creatinin>3N
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Robert Debré Service Pédiatrie-Hémato-immunologie
Paris, Île-de-France Region, 75019
About this study
Official title: MK III Trial: Analgesic Effect in Children of Low-Dose Ketamine for Mucositis Treated by Patient-Controlled Analgesia With Morphine
Hypothesis : Low dose ketamine has an analgesic effect in children with mucositis treated by patient-controlled analgesia with morphine
Read the detailed description
Double blind versus placebo multicenter Phase III trial of kétamine in children with chemotherapy induced-mucositis treated by patient-controlled analgesia with morphine
- Being tested
- Low dose ketamine
- Keywords
- Mucositis, Pain, Morphine, Ketamine
- Medical subject headings
- Neoplasms, Mucositis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose ketamineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startFeb 2003
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Evelyne JACQZ-AIGRAIN, Pr,MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224692
- Sponsor's protocol ID
- P010918
- Other IDs
- CRC01022
- Status last verified
- Oct 2006
- First submitted
- 19 Sep 2005
- Last updated
- 26 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MK III Trial: Analgesic Effect in Children of Low-Dose Ketamine for Mucositis Treated by Patient-Controlled Analgesia With Morphine
- ClinicalTrials.gov ID
- NCT00224692
- Acronym / sponsor ID
- P010918
- Keywords
- Mucositis, Pain, Morphine, Ketamine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 50 participants
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2003
- Study completion
- Aug 2006
- First posted
- 23 Sep 2005 (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.
Hypothesis : Low dose ketamine has an analgesic effect in children with mucositis treated by patient-controlled analgesia with morphine
Detailed description
Double blind versus placebo multicenter Phase III trial of kétamine in children with chemotherapy induced-mucositis treated by patient-controlled analgesia with morphine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Painful mucositis
- Child from 5 to 18 years.
- Presenting mucitis induced by chemotherapy or a conditioning of graft hematopoïetic.
- A pain not controlled by systematic paracetamol (10mg/kg/4h) or a the propacetamol (20mg/kg/4h).
- Not presenting a neurological or psychological difficulty at the use of the PCA or a EVA.
Key exclusion criteria (8 listed)
- The child was already included in the study.
- The age of psychomotor development is lower than 5 years
- Presence of a depression or a major depressive episode according to definition DSM IV.
- Hepatic or renal anomaly major (rank 3 or 4 of the scale of toxicity NCI CTC v2.0)
- Bilirubin>3N
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 |
|---|---|---|
| Low dose ketamine | Drug | – |
Primary outcome
Pain score
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2006.
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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.
Evelyne JACQZ-AIGRAIN, Pr,MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low dose ketamine in people with Cancer and Mucositis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 7 inclusion and 8 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: stopped early, as of the sponsor's last update on 26 Oct 2006. 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 France. 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 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 was stopped early. Results are not available in the source record.
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?
Pain score. 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 26 Oct 2006.