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CompletedNCT01776515Updated Jan 28, 2013

Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Low Back Pain Patients

A Phase 1 interventional study of Tramadol hydrochloride/Acetaminophen Tab. and Tramadol hydrochloride/Acetaminophen SR Tab. in Low Back Pain, sponsored by Daewon Pharmaceutical Co., Ltd.. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2013-01-28.

Sponsored by Daewon Pharmaceutical Co., Ltd. · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Ages
20 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate effectness of Tramadol Hydrochloride/Acetaminophen SR Tab. and Tramadol Hydrochloride/Acetaminophen Tab. in patients with low back pain.

02

Conditions studied

  • Low Back Pain

Keywords

  • Low back pain
  • Wontran
  • Wontran SR Tab.
  • Tramadol Hydrochloride/Acetaminophen
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

Browse Back Pain studies →

Lead sponsor

Daewon Pharmaceutical Co., Ltd. is the lead sponsor of 48 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Adult males/Females aged over 20 years
  2. Patient with low back pain who needs analgesic administration
  3. Patient with low back pain Who correspond with Class 1, 2 in Quebec Task Force Classification
  4. Pain VAS Value over 40 mm
  5. Subjects who voluntarily or legal guardian agreed with written consent

Exclusion criteria

Exclusion Criteria:

  1. Patients with severe GI tract disorder, liver disease, renal disease, heart disease, hypertension
  2. Patients with obvious secondary cause(metastatic cancer, fracture, infectious disease)
  3. Patients who had taken back surgery within 24 weeks from the screening point
  4. Patients who had taken opioid drug, psychotropic drug within 4 weeks from the screening point
  5. Patients who had taken steroid drug(oral, injection) within 4 weeks from the screening point
05

Study design

Phase
Phase 1

Study arms

  • Active comparator
    Tramadol hydrochloride/Acetaminophen Tab.

    Drug: Tramadol hydrochloride/Acetaminophen Tab.

  • Experimental
    Tramadol hydrochloride/Acetaminophen SR Tab.

    Drug: Tramadol hydrochloride/Acetaminophen SR Tab.

Interventions

  • DrugTramadol hydrochloride/Acetaminophen Tab.
  • DrugTramadol hydrochloride/Acetaminophen SR Tab.
06

What researchers measure

Primary outcomes

  1. Changes in '100 mm pain VAS' value from baseline

    Time frame: 0, 1, 7, 14, 28 day

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01776515
Lead sponsor
Daewon Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jan 28, 2013
Start date
Jan 2012
Primary completion
Mar 2012
Completion
Jun 2012
Last update
Jan 28, 2013
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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