Chronic PainPhase 2KiCK PainNCT01755169

Ketamine in Chronic Kid's (KiCK) Pain

A Phase 2 study testing Ketamine in people with Chronic Pain, run by Medical University of South Carolina at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study is designed to select the most tolerable dose of oral ketamine for children with chronic pain. Children will be given either placebo or one of three dosages of oral ketamine for 2 weeks. The dosage that is most tolerable will be selected for further study. Read more about this study

Who is it for?: Ages 8 to 20 years
Conditions the study is for: Chronic Pain
What is being tested?: Ketamine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 7 participants
Where: 1 siteUnited States
Study dates: Jan 2013to May 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 8 to 20 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Subject, parent, or guardian willing and able to give informed consent
NRS for pain over the past 24 hours >4 at baseline
Chronic pain, which has been present for >3 months, or persisting longer than is normal for the underlying diagnosis
Chronic pain related to physiologic diagnoses including but not limited to: cancer, rheumatologic disease, sickle cell anemia, cystic fibrosis, pancreatitis, and neuromuscular disease (e.g. Duchenne muscular dystrophy)
Able to tolerate and cooperate with neurocognitive assessment
Age 8-20 years old

Who cannot join

If they are known or suspected to have drug addiction
Uncontrolled psychiatric disorder such as depression, schizophrenia, or bipolar disorder
Uncontrolled hypertension
Known liver disease or elevation of AST or ALT greater than 3 times the upper limit of normal.
Previous intolerance or allergic reaction to ketamine
Pregnancy
Use of CYP3A4 inhibitors or inducers within the 2-week period prior the study drug administration or within 5 half-lives of the respective medication, whichever is longer, until study conclusion.
Consumption of grapefruit or grapefruit products from at least 2 weeks prior to study drug administration until study conclusion.

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical University of South Carolina
Charleston, South Carolina, 29425

Other trials in United States

About this study

Read the detailed description

Children with chronic pain are randomized to one of four arms (three study drug arms, one placebo arm) in a randomized, double-blinded fashion. Children are treated for 2 weeks and then monitored for an additional 12 weeks. Study participation is a total of 14 weeks.

Conditions: Chronic Pain
Being tested: Ketamine, Placebo
Keywords: Chronic pain, Child, Pediatric, Ketamine
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KetamineDrug
Also called Ketalar
Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).
PlaceboDrug

Study groups in NCT01755169
Study group	Role	What they receive
Ketamine 0.25 mg/kg/dose	Experimental	A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks. Receives: Drug: Ketamine
Ketamine 0.5 mg/kg/dose	Experimental	A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks. Receives: Drug: Ketamine
Ketamine 1 mg/kg/dose	Experimental	A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks. Receives: Drug: Ketamine
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Dose Limiting Toxicity
A total of 7 patients enrolled on the trial. However, 2 participants withdrew from the trial before they were randomized and 1 participant withdrew from the trial before being treated. Hence, the total number of patients for assessment is 4.
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013May 2015

First posted24 Dec 2012 (estimated)
Study startJan 2013
Primary completionMay 2015
Study completionMay 2015

Why it stopped: Inability to enroll sufficient patients

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic PainStudies of the same condition, open and under way.
More trials run by Medical University of South CarolinaThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01755169
Sponsor's protocol ID: KiCK Pain
Acronym: KiCK Pain
Status last verified: Nov 2016
First submitted: 18 Dec 2012
Last updated: 23 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No: Only aggregate data will be shared.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ketamine in Chronic Kid's (KiCK) Pain
ClinicalTrials.gov ID: NCT01755169
Acronym / sponsor ID: KiCK Pain / KiCK Pain
Conditions: Chronic Pain
Keywords: Chronic pain, Child, Pediatric, Ketamine
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Inability to enroll sufficient patients
Enrolment: 7 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Study start: Jan 2013
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 24 Dec 2012 (estimated)
Results: Posted 23 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Ketamine 0.25 mg/kg/dose	Experimental	Drug: KetamineA 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine 0.5 mg/kg/dose	Experimental	Drug: KetamineA 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine 1 mg/kg/dose	Experimental	Drug: KetamineA 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 8 to 20 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

Subject, parent, or guardian willing and able to give informed consent
NRS for pain over the past 24 hours >4 at baseline
Chronic pain, which has been present for >3 months, or persisting longer than is normal for the underlying diagnosis
Chronic pain related to physiologic diagnoses including but not limited to: cancer, rheumatologic disease, sickle cell anemia, cystic fibrosis, pancreatitis, and neuromuscular disease (e.g. Duchenne muscular dystrophy)
Able to tolerate and cooperate with neurocognitive assessment

Key exclusion criteria (8 listed)

If they are known or suspected to have drug addiction
Uncontrolled psychiatric disorder such as depression, schizophrenia, or bipolar disorder
Uncontrolled hypertension
Known liver disease or elevation of AST or ALT greater than 3 times the upper limit of normal.
Previous intolerance or allergic reaction to ketamine

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
KetamineAlso: KetalarParticipants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).	Drug	Ketamine 0.25 mg/kg/dose, Ketamine 0.5 mg/kg/dose, Ketamine 1 mg/kg/dose
Placebo	Drug	Placebo

Primary outcome

Number of Participants With Dose Limiting Toxicity
Time frame: 2 weeks
A total of 7 patients enrolled on the trial. However, 2 participants withdrew from the trial before they were randomized and 1 participant withdrew from the trial before being treated. Hence, the total number of patients for assessment is 4.

Results and safety

Results posted to the registry on 23 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ketamine 0.25 mg/kg/Dose	2	2
Ketamine 0.5 mg/kg/Dose	1	1
Ketamine 1 mg/kg/Dose	0	0
Placebo	1	1

Primary outcome: Number of Participants With Dose Limiting Toxicity

Time frame: 2 weeks. Count of participants. Unit: Participants

Measure	Ketamine 0.25 mg/kg/Dose n = 2	Ketamine 0.5 mg/kg/Dose n = 1	Ketamine 1 mg/kg/Dose n = 0	Placebo n = 1
Value	0	0	0	0

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ketamine 0.25 mg/kg/Dose	0 of 2 (0%)	0 of 2 (0%)	Not reported
Ketamine 0.5 mg/kg/Dose	0 of 1 (0%)	0 of 1 (0%)	Not reported
Ketamine 1 mg/kg/Dose	0 of 0	0 of 0	Not reported
Placebo	0 of 1 (0%)	0 of 1 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Only aggregate data will be shared.

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RecruitingObservational study
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Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
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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.

Amy-Lee Bredlau, MD principal investigator

Medical University of South Carolina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ketamine in people with Chronic Pain, run by Medical University of South Carolina at 1 site in United States.

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 6 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 23 Jan 2017. 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 United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Dose Limiting Toxicity (time frame: 2 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 NCT01755169.

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 23 Jan 2017.