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

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

Tracking Information

• First Submitted Date: December 18, 2012
• First Posted Date: December 24, 2012
• Results First Submitted Date: November 28, 2016
• Results First Posted Date: January 23, 2017
• Last Update Posted Date: January 23, 2017
• Study Start Date: January 2013
• Actual Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (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: Ketamine in Chronic Kid's (KiCK) Pain
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Chronic Pain

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: November 28, 2016): 7
• Original Estimated Enrollment (submitted: December 21, 2012): 52
• Actual Study Completion Date: May 2015
• Actual Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 8 Years to 20 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01755169
• Other Study ID Numbers: KiCK Pain
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Only aggregate data will be shared.

• Current Responsible Party: Amy-Lee Bredlau, Medical University of South Carolina
• Original Responsible Party: Same as current
• Current Study Sponsor: Medical University of South Carolina
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Amy-Lee Bredlau, MD; Medical University of South Carolina

• PRS Account: Medical University of South Carolina
• Verification Date: November 2016