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L-carnitine vs Placebo for the Treatment of Muscle Cramps After Imatinib in Gastrointestinal Stromal Tumors

NCT03426722 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2020-07-13

No results posted yet for this study

Summary

we aim to evaluate the efficacy of L-carnitine for the treatment of muscle cramps after imatinib in patients with GIST and apply in the future.

Conditions

  • Gastrointestinal Stromal Tumors (GISTs)

Interventions

DRUG

L-carnitine

* L-carnitine VS Placebo is randomized (1:1) * L-carnitine 500mg TID(PO), * First evaluation will be performed at 8 weeks and then unblinding will be done. If symptoms continue after treatment, dose escalation in L-carnitine group by 1000mg TID (PO). If symptoms continue after treatment in Placebo group, L-carnitine 500mg TID(PO) will be given.

DRUG

Placebo

Placebo 500mg TID(PO)

Sponsors & Collaborators

  • Hanmi Pharmaceutical Company Limited

    collaborator INDUSTRY

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Yoon-Koo Kang, MD, PhD · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2019-12-24
Completion
2019-12-24

Countries

  • South Korea

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03426722 on ClinicalTrials.gov