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OpenTrials
Completed

NCT Number: NCT01779271

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

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.

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Key information

Conditions

Acute Upper Respiratory Infection Body Temperature Changes Fever Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chung-Ang University Hospital, South Korea

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over 15 years old
  • Male and Female
  • Patients with fever over 38.0°C due to cold (acute upper respiratory tract infection)
  • Patients with upper respiratory tract infection outbreak within 2 days and who did not received drug administration
  • Subjects who voluntarily or legal guardian agreed with written consent

Exclusion criteria

  • Fever reducer administration Within 4 hours from the screening point
  • Any incidence of febrile crisis from the past six months
  • Patients with Ulcers, gastrointestinal disorders which are confirmed by endoscopy
  • Patients with continuously administrating gastrointestinal disorder related drug
  • Patients with severe blood damage
  • Severe hepatic impairment (ALT, AST value more than 2 times the upper limit of the normal range)
  • With severe renal impairment (serum creatinine value is more than 2 times the upper limit of the normal range)
  • Patients with severe left ventricular dysfunction

Treatment and study plan

Pelubiprofen

Drug

Other names: Pelubiprofen 30 mg

Loxoprofen

Drug

Other names: Loxoprofen 60mg

Primary outcomes

  1. Changes in Body temperature from baseline

    Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6 Hour

Sponsors and collaborators

Lead sponsor

Daewon Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2013
Primary completion
2016
First posted
Jan 30, 2013
Registry last updated
Oct 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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