Efficacy and Safety of Oxycodone/Naloxone (Targin®) in Persistent Moderate to Severe Low Back Pain Following NSAIDs Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-21

Study Completion Date

2020-09-17

Brief Summary

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The purpose of this study is to evaluate the efficacy of the study drug (Targin®) after 8 weeks of treatment in patients with moderate to severe low back pain who are uncontrolled\* by NSAIDs.

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Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Brand Name: Targin®

Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral

Group Type EXPERIMENTAL

Brand Name: Targin®

Intervention Type DRUG

Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral

Interventions

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Brand Name: Targin®

Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Korean patients age ≥ 19 years old
2. Patients having moderate to severe low back pain (NRS pain score ≥4) for ≥ 7 days and ≤ 90 days not satisfactorily controlled with NSAIDs
3. Patients showing average NRS pain score ≥4 over the last 1 week at screening point
4. In case of previous opioids medication history, opioids wash-out period \> 30 days before enrolment
5. Patients who is willing to voluntarily sign informed consent

Exclusion Criteria

1. Patients with any history of hypersensitivity to oxycodone, naloxone or related products
2. Low back pain coming from cancer, infectious disease, psychiatric issue or congenial cause
3. Pregnant or lactating women

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No