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

Low Back Pain Clinical Trial

Official title:

A Randomized, Double-blind, Active-controlled, Parallel, Multicenter Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Low Back Pain Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01776515
• Other study ID #: DW 0919 301 Version 1.00
• Status: Completed
• Phase: Phase 1
• First received: January 21, 2013
• Last updated: January 23, 2013
• Start date: January 2012
• Est. completion date: June 2012

Study information

• Verified date: January 2013
• Source: Daewon Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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:

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

Study Design

N/A

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Drug:
• Tramadol hydrochloride/Acetaminophen Tab.

• Tramadol hydrochloride/Acetaminophen SR Tab.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daewon Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in '100 mm pain VAS' value from baseline		0, 1, 7, 14, 28 day