Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Acute Toothache Patients After Teeth Extraction Surgery

Acute Toothache Patients Above Moderate Pain After Teeth Extraction Surgery 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 Acute Toothache Patients After Teeth Extraction Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01920386
• Other study ID #: DW 0919 302 Version 1.0
• Status: Completed
• Phase: Phase 3
• First received: August 8, 2013
• Last updated: October 11, 2016
• Start date: June 2013

Study information

• Verified date: October 2016
• 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

A randomized, double-blind, active-controlled, parallel, multicenter Phase 3 study of Tramadol hydrochloride/Acetaminophen SR Tab. & Tramadol hydrochloride/Acetaminophen Tab. in Acute Toothache Patients above Moderate Pain after Teeth Extraction Surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Adult males/Females aged over 20 years

2. Patients with over 2 impacted wisdom teeth in the upper and lower jaws

3. Pain VAS Value over 50 mm evaluated as 100mm VAS

4. Subjects who voluntarily or legal guardian agreed with written consent

Exclusion Criteria:

1. Patients with severe heart disease, uncontrol hypertension, diabetes

2. Patients who had taken a long period NSAID (eg. celecoxib, rofecoxib naproxen etc) within 3 days from the screening point

3. Patients who had taken short-time anesthetic drugs and analgesics within 12 hours from the screening point (except short-time anesthetics before or during surgery)

4. Patients with aspirin asthma(asthma seizure caused by NSAIDs) or medical history

5. Patients with severe respiratory depression

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Toothache Patients Above Moderate Pain After Teeth Extraction Surgery
• Toothache

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	SPID ; Sum of the pain intensity differences		0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour	No