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

Last updated: October 7, 2016
Sponsor: Daewon Pharmaceutical Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Fever

Respiratory Syncytial Virus (Rsv) Infection

Common Cold (Pediatric)

Treatment

N/A

Clinical Study ID

NCT01779271
Plb CD 301 Version 3.10
  • Ages > 15
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 notreceived drug administration

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

Exclusion

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 thenormal range)

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

  8. Patients with severe left ventricular dysfunction

Study Design

Total Participants: 183
Study Start date:
January 01, 2013
Estimated Completion Date:

Connect with a study center

  • Chung-Ang University Hospital, South Korea

    Seoul,
    Korea, Republic of

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.