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Ketamine in Chronic Kid's (KiCK) Pain (KiCK Pain)

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ClinicalTrials.gov Identifier: NCT01755169
Recruitment Status : Terminated (Inability to enroll sufficient patients)
First Posted : December 24, 2012
Results First Posted : January 23, 2017
Last Update Posted : January 23, 2017
Sponsor:
Information provided by (Responsible Party):
Amy-Lee Bredlau, Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE December 18, 2012
First Posted Date  ICMJE December 24, 2012
Results First Submitted Date  ICMJE November 28, 2016
Results First Posted Date  ICMJE January 23, 2017
Last Update Posted Date January 23, 2017
Study Start Date  ICMJE January 2013
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2012)
Dosage of ketamine that is most tolerable [ Time Frame: 2 weeks ]
The dosage that is best tolerated by participants will be selected as the dosage to be studied in future trials.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2012)
  • Dosage of ketamine with least impact on neurocognition [ Time Frame: 14 weeks ]
    If more than one dosage of oral ketamine is tolerable, then the dosage with the least neurocognitive effect will be chosen as the dosage to carry into further trials.
  • Dosage of ketamine with best control of chronic pain [ Time Frame: 2 weeks ]
    If there are more than one dosages that are tolerable with acceptable neurocognitive impact, then the dosage that has the most impact on pain will be selected for further study.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: December 21, 2012)
Pharmacokinetics [ Time Frame: 1 week ]
Any participants consenting for additional blood draws will have pharmacokinetics draws done to allow description of the pharmacokinetics of oral ketamine in children with chronic pain.
 
Descriptive Information
Brief Title  ICMJE Ketamine in Chronic Kid's (KiCK) Pain
Official Title  ICMJE Ketamine in Chronic Kid's (KiCK) Pain
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain
Intervention  ICMJE
  • Drug: Ketamine
    Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).
    Other Name: Ketalar
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Ketamine 0.25 mg/kg/dose
    A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
    Intervention: Drug: Ketamine
  • Experimental: Ketamine 0.5 mg/kg/dose
    A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
    Intervention: Drug: Ketamine
  • Experimental: Ketamine 1 mg/kg/dose
    A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
    Intervention: Drug: Ketamine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 28, 2016)
7
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2012)
52
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01755169
Other Study ID Numbers  ICMJE KiCK Pain
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Only aggregate data will be shared.
Responsible Party Amy-Lee Bredlau, Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Amy-Lee Bredlau, MD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP