Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Low Back Pain Patients
This study has been completed.
Sponsor:
Daewon Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01776515
First received: January 21, 2013
Last updated: January 23, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Low Back Pain |
Drug: Tramadol hydrochloride/Acetaminophen Tab. Drug: Tramadol hydrochloride/Acetaminophen SR Tab. |
Phase 1 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Daewon Pharmaceutical Co., Ltd.:
Primary Outcome Measures:
- Changes in '100 mm pain VAS' value from baseline [ Time Frame: 0, 1, 7, 14, 28 day ]
| Study Start Date: | January 2012 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Tramadol hydrochloride/Acetaminophen Tab. | Drug: Tramadol hydrochloride/Acetaminophen Tab. |
| Experimental: Tramadol hydrochloride/Acetaminophen SR Tab. | Drug: Tramadol hydrochloride/Acetaminophen SR Tab. |
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Daewon Pharmaceutical Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT01776515 History of Changes |
| Other Study ID Numbers: | DW 0919 301 Version 1.00 |
| Study First Received: | January 21, 2013 |
| Last Updated: | January 23, 2013 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Daewon Pharmaceutical Co., Ltd.:
|
Low back pain Wontran Wontran SR Tab. Tramadol Hydrochloride/Acetaminophen |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Acetaminophen Tramadol Antipyretics Physiological Effects of Drugs |
Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Narcotics Central Nervous System Depressants Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 23, 2013