NCT01776515

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_1 low-back-pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
Last Updated

January 28, 2013

Status Verified

January 1, 2013

Enrollment Period

2 months

First QC Date

January 21, 2013

Last Update Submit

January 23, 2013

Conditions

Low Back Pain

Keywords

Low back painWontranWontran SR Tab.Tramadol Hydrochloride/Acetaminophen

Outcome Measures

Primary Outcomes (1)

  • Changes in '100 mm pain VAS' value from baseline

    0, 1, 7, 14, 28 day

Study Arms (2)

Tramadol hydrochloride/Acetaminophen Tab.

ACTIVE COMPARATOR
Drug: Tramadol hydrochloride/Acetaminophen Tab.

Tramadol hydrochloride/Acetaminophen SR Tab.

EXPERIMENTAL
Drug: Tramadol hydrochloride/Acetaminophen SR Tab.

Interventions

Tramadol hydrochloride/Acetaminophen Tab.DRUG
Tramadol hydrochloride/Acetaminophen Tab.
Tramadol hydrochloride/Acetaminophen SR Tab.DRUG
Tramadol hydrochloride/Acetaminophen SR Tab.

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back Pain

Interventions

TramadolAcetaminophen

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipidsAcetanilidesAnilidesAmidesAniline Compounds

Study Design

Study Type
interventional
Phase
phase 1
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2013

First Posted

January 28, 2013

Study Start

January 1, 2012

Primary Completion

March 1, 2012

Study Completion

June 1, 2012

Last Updated

January 28, 2013

Record last verified: 2013-01