Phase 3 Study of Pelubiprofen & Loxoprofen in Patients With Upper Respiratory Tract Infection

Fever Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01779271
• Other study ID #: Plb CD 301 Version 3.10
• Status: Completed
• Phase: Phase 3
• First received: January 21, 2013
• Last updated: October 7, 2016
• Start date: January 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

Multi-center, Randomized, Double blind, Controlled Parallel-group Comparative Phase 3 Clinical trial to assess the efficacy and safety of Pelubiprofen Compared to Loxoprofen in patients with Acute upper respiratory infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

1. Over 15 years old

2. Male and Female

3. Patients with fever over 38.0°C due to cold (acute upper respiratory tract infection)

4. Patients with upper respiratory tract infection outbreak within 2 days and who did not received drug administration

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

Exclusion Criteria:

1. Fever reducer administration Within 4 hours from the screening point

2. Any incidence of febrile crisis from the past six months

3. Patients with Ulcers, gastrointestinal disorders which are confirmed by endoscopy

4. Patients with continuously administrating gastrointestinal disorder related drug

5. Patients with severe blood damage

6. Severe hepatic impairment (ALT, AST value more than 2 times the upper limit of the normal range)

7. With severe renal impairment (serum creatinine value is more than 2 times the upper limit of the normal range)

8. Patients with severe left ventricular dysfunction

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 Upper Respiratory Infection
• Fever
• Infection
• Respiratory Tract Infections

Intervention

Drug:
• Pelubiprofen

• Loxoprofen

Locations

Country	Name	City	State
Korea, Republic of	Chung-Ang University Hospital, South Korea	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewon Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Body temperature from baseline		0, 0.5, 1, 1.5, 2, 3, 4, 6 Hour	No