NCT01755169

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_2 chronic-pain

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

December 18, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 24, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

January 23, 2017

Completed
Last Updated

January 23, 2017

Status Verified

November 1, 2016

Enrollment Period

2.3 years

First QC Date

December 18, 2012

Results QC Date

November 28, 2016

Last Update Submit

November 28, 2016

Conditions

Chronic Pain

Keywords

Chronic painChildPediatricKetamine

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 weeks

Study Arms (4)

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.

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.

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.

Drug: Ketamine

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

KetamineDRUG

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

Also known as: Ketalar
Ketamine 0.25 mg/kg/doseKetamine 0.5 mg/kg/doseKetamine 1 mg/kg/dose
PlaceboDRUG
Placebo

Eligibility Criteria

Age8 Years - 20 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 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

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

Results Point of Contact

Title
Dr. Amy-Lee Bredlau
Organization
MUSC
bredlau@musc.edu
843-876-0444

Study Officials

  • Amy-Lee Bredlau, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Pediatric Brain Tumor Program

Study Record Dates

First Submitted

December 18, 2012

First Posted

December 24, 2012

Study Start

January 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

January 23, 2017

Results First Posted

January 23, 2017

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Only aggregate data will be shared.

Locations

US(1)