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Kim, Kim, Choi, Ahn, Koh, Kim, and Lee: Comparison of the Efficacy and Safety Profiles of a Pelubi Sustained Release Tab Versus a Pelubi Tab in Patients with Chronic Back Pain: A Randomized, Double-Blind, Multi-Institution Phase III Study
Original Article

Journal of Korean Spine Surg 2016;23(2):84-92.

Published online: 30 June 2016

DOI: https://doi.org/10.4184/jkss.2016.23.2.84

Comparison of the Efficacy and Safety Profiles of a Pelubi Sustained Release Tab Versus a Pelubi Tab in Patients with Chronic Back Pain: A Randomized, Double-Blind, Multi-Institution Phase III Study

Ki Taek Kim, M.D., Tae Kyun Kim, M.D.∗, , Ji Woong Choi, M.D.∗, Jae Sung Ahn, M.D.†, Young Do Koh, M.D.‡, Young Woo Kim, M.D.∮, Jung Hee Lee, M.D.∥

Department of Orthopedic Surgery, Kyung Hee University, Kangdong Hospital, Seoul, Korea

∗Department of Orthopaedic Surgery, School of Medicine, WonkwangUniversity, Iksan, Korea

†Department of Orthopedic Surgery, Chungnam National University School of Medicine, Daejeon, Korea

‡Department of Orthopedic Surgery, Ewha Womans University School of Medicine, Seoul, Korea

∥Department of Orthopaedic Surgery, School of Medicine, Hallym Universtiy, Dong Tan Sacred Heart Hospital, Seoul, Korea

∮ Department of Orthopedic Surgery, College of Medicine, Kyung Hee University, Seoul Medical Center, Seoul, Korea

Corresponding author: Tae Kyun Kim, M.D. Department of Orthopaedic Surgery, School of Medicine, Wonkwang University, 344-2, Shinyong-dong, Iksan, Jeon buk, Korea TEL: +82-63-859-1360, FAX: +82-63-852-9329 E-mail: osktg@wonkwang.ac.kr

Received 24 June 201511 August 2015       Accepted 26 April 2016

Copyright © 2016 Korean Society of Spine Surgery

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Study Design

A randomized, double-blind, multi-institution, phase III study.

Objectives

To evaluate the efficacy and safety of the Pelubi Sustained Release (SR) Tab in patients with chronic back pain, in comparison with the Pelubi Tab, whose efficacy has already been approved, a phase 3 clinical trial was conducted.

Summary of Literature Review

The Pelubi Tab Has shown clinical efficacy in patients with back pain.

Materials and Methods

From April 11, 2014 to July 24, 2014, 166 chronic back pain patients were recruited as subjects through a multi-institution, double-blind, random sample. We compared the experimental and control groups’ clinical efficacy, which was estimated by the 100-mm Pain Visual Analog Scale (VAS) after 28 days of medication. We also compared the treatment efficacy of both drugs by using a variation of the Oswestry Disability Index (ODI) and Physician Global Assessment (PGA), with the total usage of relief medicine. The side effects and clinical pathology were also noted.

Results

Neither group showed a significant difference in 100-mm Pain VAS or ODI variation (p=0.1702, p=0.9041). There was no statistically significant difference between the experimental group and the control group in PGA or total usage of relief medicine. The ODI and PGA variation were not worse in the experimental group than the control group. The two groups showed no significant differences in side effects (p=0.9708).

Conclusions

This study found that the Pelubi SR Tab applied to back pain patients was not inferior to the Pelubi Tab and did not show any significant difference in terms of safety. The Pelubi SR Tab can be used with the same expectation of safety as the Pelubi Tab.

Keywords: Pelubi SR Tab, Random sampling, Double blind

REFERENCES

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Table 1.
Inclusion and exclusion criteria
선정기준
01) 만 18세 이상의 남·녀
02) 임상시험시작(스크리닝) 시점을 기준으로 12주 이상 되고 진통제 투여가 요구되는 요통환자
03) Quebec Task Force Classification 상 Class 1,2에 해당되는 요통환자
04) 방문2 당시 통증검사(Pain VAS) 결과가 40 mm 이상인 환자
05) 본 임상시험에 참가할 것을 자발적 또는 법적인 보호자가 서면 동의한 환자
제외기준
01) 심각한 위장질환, 간질환, 신질환, 심장질환, 고혈압을 앓고 있는 환자
02) 이차성 원인이 명백한 환자(전이성 암, 골절, 감염성 질환)
03) 임상시험 참여(스크리닝 시점) 전 24주 이내 허리 수술을 받은 환자
04) 임상시험 참여(스크리닝 시점) 4주 이내 통증 감각에 영향을 미칠 수 있는 향정신성 의약품, 마약성 진통제를 투약한 경험이 있는 환
자
05) 임상시험 참여(스크리닝 시점) 4주 이내 스테로이드를 경구 투여 하였거나 주사를 맞은 경우
06) 임상시험 참여(스크리닝 시점) 2주 이내에 MAO억제제를 투여한 경험이 있는 환자
07) 심한 호흡억제상태 환자
08) 두부손상, 뇌의병변이 있는 경우로 의식혼탁의 위험이 있는 환자
09) 아스피린 천식(비스테로이드성 소염진통제에 의한 천식발작 유발) 또는 병력이 있는 환자
10) 약물로 조절되지 않는 간질 환자
11) 시험약의 성분에 과민성이 있는 환자
12) 비스테로이드성 소염진통제의 처방이 금기가 되는 병발질환 혹은 병용약물 복용자
13) 만성적으로 위장관계 약물(예를 들면 H2-blockers, misoprostol, 또는 proton pump inhibitors)을 투여중인 환자로 시험기간 중 투
여를 중단할 수 없는 자
14) 스크리닝 검사에서 임상적으로 유의한 비정상적인 수치를 보인 자(ALT, AST, BUN, Serum Creatinine의 수치가 정상 상한치의 2배
초과)
15) 임신 혹은 수유 중인 여성. 고효능의 피임방법을 사용하지 않는 가임 여성, 매우 효과적인 피임방법은 임플란트, 주사제, 복합 경구용
피임약, 몇몇의 자궁내 장치(IUDs), 성적 금욕 또는 정관 절제술을 받은 파트너 등의 단독 또는 병용으로 지속적이고 올바르게 사용
할 경우 낮은 실패율(예, 남성의 콘돔 사용 또는 피임용 격막)은 살정제(예, 거품형 겔)와 함께 사용할 경우 허용가능
16) 약물이나 알코올에 의존성이 있는 대상자
17) 중증의 혈액이상 환자
18) 관상동맥우회로술(CABG) 전후에 발생하는 통증의 치료가 요구되는 환자
19) 이 약은 유당을 함유하고 있으므로 드물게 일어나는 유전적인 갈락토오스 불내성, 락타아제 결핍증(Lapp deficiency) 또는 글루코오
스-갈락토오스 흡수장애 환자
20) 기타 연구자가 부적합하다고 판단한 환자
Table 2.
Schedule table for clinical practice
Period Screening & Wash out2 Treatment
Visit 1 2 3 4 or 중도탈락
Day D 1 ∼ -14 D 1 D 14 ± 3 D 28 ± 3
서면동의서 O      
인구학적 조사 O      
병력 및 약물치료력 조사 O      
활력 징후 및 신체 검진1 O O O O
임신반응 검사 O3     O
임상병리 검사 O4     O
심전도검사 O5     O
선정기준/제외기준 평가 O O    
진통제 투약중지2 O      
진통제 중지확인2   O    
무작위배정   O    
100 mm Pain VAS O O O O
Oswestry Disability Index(ODI) O O O O
Physician's Global Assessment       O
병용약물변화 확인   O O O
구제약 처방 O O O  
구제약의 사용 확인   O O O
임상시험용의약품 배포   O O  
순응도 확인     O O
이상반응 확인     O O

1: 신장은 Visit1에서만 측정하였다.2: 진통제를 투여하고 있던 대상자의 경우, Washout Period는 투여 받고 있던 약물에 따라 3∼14일 간으로 하였다. 스크리닝 기간은 체외배출기간을 포함하여 최대 2주를 초과할 수 없었다.3: 가임기 여성의 경우에 한하여 소변으로 HCG 검사를 실시하였다.4: 스크리닝을 기준으로 1주 이내 검사결과가 있을 시 대체 가능하도록 하였다. - 혈액학적 검사: WBC, RBC, Hemoglobin, Hematocrit, Platelet count, WBC Diffcount - 혈액화학적 검사: Na, K, Ca, Cl, BUN, Creatinine, Uric acid, Total bilirubin, Albumin, Total protein, Creatine Kinase, ALT, AST, r-GT, Alkaline Phospha-tase, glucose, Total cholesterol, Triglyceride - 혈액응고검사: PT, PTT - 소변검사: Protein, Glucose, Color, Urobilinogen, WBC, RBC - 임신반응검사: Urine hCG(가임기 여성만 실시)5: 스크리닝을 기준으로 4주 이내 검사결과가 있을 시 대체 가능하도록 하였다.

Table 3.
100 mm Pain VAS
  Pelubiprofen (SR) (N=68) Pelubiprofen (N=71) p-value (t-test)
Visit 2 64.10±10.16 65.15±9.96 0.5385
Visit 3 44.18±17.71 42.65±20.32 0.6377
Visit 4 26.66±17.17 32.17±19.21 0.0774
Difference (Visit 4-Visit 2) −37.44±18.65 −32.99±19.41 0.1702
p-value (paired t-test) <0.0001 <0.0001  
Table 4.
ODI score
Difference (Visit 4-visit 2) Pelubiprofen (SR) (N=68) Pelubiprofen (N=71) p-value
Pain intensity −1.32±0.84 −1.45±1.07 0.4343
Personal care −0.69±0.80 −0.68±0.73 0.9074
Lifting −0.79±0.03 −0.89±0.96 0.5826
Walking −0.54±0.85 −0.31±0.75 0.0873
Sitting −0.63±0.81 −0.85±0.82 0.1265
Standing −0.65±0.69 −0.62±0.64 0.8084
Sleeping −0.71±0.85 −0.65±0.86 0.6902
Sex life −0.79±0.89 −0.52±0.74 0.1183
Social life −0.91±0.93 −0.86±0.96 0.7430
Traveling −0.66±0.77 −0.61±0.75 0.6621
Table 5.
Physician's global assessment
  Pelubiprofen (SR) N (%) Pelubiprofen N (%) Total N (%) p-value
Response 59 (86.76) 61 (85.92) 120(86.33) 0.8842
No response 9(13.24) 10 (14.08) 19(13.67)  
Total 68(48.92) 71(51.08) 139(100.00)  
Table 6.
Total Usage of relief medicine
    Pelubiprofen (SR) N(%) Pelubiprofen N(%) Total N(%) p-value
Taking medicine Yes 17(25.00) 21(29.58) 38(27.34) 0.5450
  no 51(75.00) 50(70.42) 101(72.66)  
Number   3.35±2.96 5.43±5.55 4.50±4.64 0.1504
Dose   3.36±2.96 5.52±5.60 4.55±4.68 0.1355
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