Low Back PainPhase 1NCT01776515

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

A Phase 1 study testing Tramadol hydrochloride/Acetaminophen Tab. and Tramadol hydrochloride/Acetaminophen SR Tab. in people with Low Back Pain, run by Daewon Pharmaceutical Co., Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Low Back Pain
What is being tested?: Tramadol hydrochloride/Acetaminophen Tab. and Tramadol hydrochloride/Acetaminophen SR Tab.
Could I receive a placebo?: No, everyone receives an active treatment
How many people: Not given
Where: No sites listed yet
Study dates: Jan 2012to Jun 2012
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

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

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.

Conditions: Low Back Pain
Being tested: Tramadol hydrochloride/Acetaminophen Tab., Tramadol hydrochloride/Acetaminophen SR Tab.
Keywords: Low back pain, Wontran, Wontran SR Tab., Tramadol Hydrochloride/Acetaminophen
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tramadol hydrochloride/Acetaminophen Tab.Drug
Tramadol hydrochloride/Acetaminophen SR Tab.Drug

Study groups in NCT01776515
Study group	Role	What they receive
Tramadol hydrochloride/Acetaminophen Tab.	Active comparator	Not described Receives: Drug: Tramadol hydrochloride/Acetaminophen Tab.
Tramadol hydrochloride/Acetaminophen SR Tab.	Experimental	Not described Receives: Drug: Tramadol hydrochloride/Acetaminophen SR Tab.

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in '100 mm pain VAS' value from baseline
Measured: 0, 1, 7, 14, 28 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Jun 2012

First posted28 Jan 2013 (estimated)
Study startJan 2012
Primary completionMar 2012
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1

IDs, dates and publications

ClinicalTrials.gov ID: NCT01776515
Sponsor's protocol ID: DW 0919 301 Version 1.00
Status last verified: Jan 2013
First submitted: 21 Jan 2013
Last updated: 28 Jan 2013
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01776515
Acronym / sponsor ID: DW 0919 301 Version 1.00
Conditions: Low Back Pain
Keywords: Low back pain, Wontran, Wontran SR Tab., Tramadol Hydrochloride/Acetaminophen
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Lead sponsor: Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: Jan 2012
Primary completion: Mar 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 28 Jan 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Number of arms: 2

Arm	Type	Receives
Tramadol hydrochloride/Acetaminophen Tab.	Active comparator	Drug: Tramadol hydrochloride/Acetaminophen Tab.
Tramadol hydrochloride/Acetaminophen SR Tab.	Experimental	Drug: Tramadol hydrochloride/Acetaminophen SR Tab.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tramadol hydrochloride/Acetaminophen Tab.	Drug	Tramadol hydrochloride/Acetaminophen Tab.
Tramadol hydrochloride/Acetaminophen SR Tab.	Drug	Tramadol hydrochloride/Acetaminophen SR Tab.

Primary outcome

Changes in '100 mm pain VAS' value from baseline
Time frame: 0, 1, 7, 14, 28 day

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2013.

Related trials for Low Back Pain

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tramadol hydrochloride/Acetaminophen Tab. and Tramadol hydrochloride/Acetaminophen SR Tab. in people with Low Back Pain, run by Daewon Pharmaceutical Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in '100 mm pain VAS' value from baseline (time frame: 0, 1, 7, 14, 28 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01776515.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2013.