NCT01369680

Brief Summary

The study is a maximum tolerated dose finding study for oral, chronic, daily administration of oral ketamine (by mouth) in children with long-term daily pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 chronic-pain

Timeline
Completed

Started May 2011

Typical duration for phase_1 chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 9, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
4 months until next milestone

Results Posted

Study results publicly available

February 11, 2013

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

1.4 years

First QC Date

May 23, 2011

Results QC Date

October 24, 2012

Last Update Submit

February 11, 2013

Conditions

Chronic Pain

Keywords

KetamineChronic painChildrenOral pain medication

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Tolerating Dose

    According to CTCae any dose causing grade 2 or worse toxicity will be an untolerated dose. Tolerability is defined as ability to take the medication for 2 weeks without having a grade 2 or worse toxicity.

    Up to 2 weeks

Secondary Outcomes (3)

  • Neurocognitive Effect

    At 14 weeks

  • Norketamine Cmax (Measured in ng/mL).

    At week 1

  • Pain Control

    Week 2

Study Arms (4)

Ketamine 0.25 mg/kg/dose

EXPERIMENTAL

The first three subjects were administered 0.25 mg/kg/dose oral ketamine.

Drug: Ketamine

Ketamine 0.5 mg/kg/dose

EXPERIMENTAL

The second group of three subjects were administered 0.5 mg/kg/dose oral ketamine.

Drug: Ketamine

Ketamine 1 mg/kg/dose

EXPERIMENTAL

The third group of three subjects were administered 1 mg/kg/dose oral ketamine.

Drug: Ketamine

Ketamine 1.5 mg/kg/dose

EXPERIMENTAL

The fourth group of three subjects were administered 1.5 mg/kg/dose oral ketamine.

Drug: Ketamine

Interventions

KetamineDRUG

Drug will be given orally three times a day at doses escalating from 0.25mg/kg/dose to 1.5mg/kg/dose in cohorts of 3. Each subject will be administered study drug for 2 weeks.

Also known as: Ketalar, Ketamine hydrochloride
Ketamine 0.25 mg/kg/doseKetamine 0.5 mg/kg/doseKetamine 1 mg/kg/doseKetamine 1.5 mg/kg/dose

Eligibility Criteria

Age8 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Subject, parent, or guardian willing and able to give informed consent
  • NRS for pain \>4
  • Chronic pain, which has been present for \>3 months, or persisting longer than is normal for the underlying diagnosis
  • Chronic pain related to 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 8-22 years old

You may not qualify if:

  • If they are known or suspected to have drug dependence or addiction
  • History of psychiatric disorder such as depression, schizophrenia, or bipolar disorder
  • History of hypertension
  • Unable to cooperate with neurocognitive assessment
  • Chronic pain related to chronic abdominal pain syndrome
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (9)

  • Green SM, Cote CJ. Ketamine and neurotoxicity: clinical perspectives and implications for emergency medicine. Ann Emerg Med. 2009 Aug;54(2):181-90. doi: 10.1016/j.annemergmed.2008.10.003. Epub 2008 Nov 6.

    PMID: 18990467BACKGROUND

  • Okon T. Ketamine: an introduction for the pain and palliative medicine physician. Pain Physician. 2007 May;10(3):493-500.

    PMID: 17525784BACKGROUND

  • Kronenberg RH. Ketamine as an analgesic: parenteral, oral, rectal, subcutaneous, transdermal and intranasal administration. J Pain Palliat Care Pharmacother. 2002;16(3):27-35. doi: 10.1080/j354v16n03_03.

    PMID: 14640353BACKGROUND

  • Visser E, Schug SA. The role of ketamine in pain management. Biomed Pharmacother. 2006 Aug;60(7):341-8. doi: 10.1016/j.biopha.2006.06.021. Epub 2006 Jul 5.

    PMID: 16854557BACKGROUND

  • Wilder RT, Flick RP, Sprung J, Katusic SK, Barbaresi WJ, Mickelson C, Gleich SJ, Schroeder DR, Weaver AL, Warner DO. Early exposure to anesthesia and learning disabilities in a population-based birth cohort. Anesthesiology. 2009 Apr;110(4):796-804. doi: 10.1097/01.anes.0000344728.34332.5d.

    PMID: 19293700BACKGROUND

  • Schwartzman RJ, Alexander GM, Grothusen JR, Paylor T, Reichenberger E, Perreault M. Outpatient intravenous ketamine for the treatment of complex regional pain syndrome: a double-blind placebo controlled study. Pain. 2009 Dec 15;147(1-3):107-15. doi: 10.1016/j.pain.2009.08.015. Epub 2009 Sep 23.

    PMID: 19783371BACKGROUND

  • Sigtermans MJ, van Hilten JJ, Bauer MCR, Arbous SM, Marinus J, Sarton EY, Dahan A. Ketamine produces effective and long-term pain relief in patients with Complex Regional Pain Syndrome Type 1. Pain. 2009 Oct;145(3):304-311. doi: 10.1016/j.pain.2009.06.023. Epub 2009 Jul 14.

    PMID: 19604642BACKGROUND

  • Bell RF. Ketamine for chronic non-cancer pain. Pain. 2009 Feb;141(3):210-214. doi: 10.1016/j.pain.2008.12.003. Epub 2009 Jan 6. No abstract available.

    PMID: 19128879BACKGROUND

  • Bredlau AL, McDermott MP, Adams HR, Dworkin RH, Venuto C, Fisher SG, Dolan JG, Korones DN. Oral ketamine for children with chronic pain: a pilot phase 1 study. J Pediatr. 2013 Jul;163(1):194-200.e1. doi: 10.1016/j.jpeds.2012.12.077. Epub 2013 Feb 10.

    PMID: 23403253DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Ketamine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Limitations and Caveats

Three subjects were lost to follow-up, limiting the data available for neuro-cognitive assessment at the last visit.

Results Point of Contact

Title
Dr. Amy-Lee Bredlau
Organization
Medical University of South Carolina
bredlau@musc.edu
843-792-2957

Study Officials

  • David Korones, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Pediatric Palliative Care

Study Record Dates

First Submitted

May 23, 2011

First Posted

June 9, 2011

Study Start

May 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

February 15, 2013

Results First Posted

February 11, 2013

Record last verified: 2013-02

Locations

US(1)