Delayed recovery from naturally infected upper respiratory tract infections by loxoprofen: a randomized controlled trial

ISRCTN	ISRCTN71443934
DOI	https://doi.org/10.1186/ISRCTN71443934
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Takashi Kawamura
Scientific

Yoshida-Honmachi
Sakyo-ku
Kyoto
606-8501
Japan

Phone	+81 75 753 2411
Email	kawax@kuhp.kyoto-u.ac.jp

Study design	Randomised double-blind placebo-controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	The Great Cold Study 2
Study objectives	Loxoprofen, one of the Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), prolongs the recovery process of naturally-infected upper respiratory tract infections
Ethics approval(s)	The Ethical Committee of Kyoto University Faculty of Medicine (No. 404, October 29, 2002)
Health condition(s) or problem(s) studied	Upper Respiratory Tract Infection (URTI)
Intervention	Patients in the intervention group take loxoprofen sodium (60 mg/tablet) and those in the control group take a placebo similar to active loxoprofen
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Loxoprofen sodium
Primary outcome measure	The interval, in days, from the onset of any URTI symptom to the disappearance of all URTI symptoms
Secondary outcome measures	Severity of the URTI symptoms
Overall study start date	01/12/2002
Completion date	31/03/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	170
Key inclusion criteria	Patients aged 18 through to 65 years who exhibit symptoms or signs in both the nose and pharynx and have visited physicians within 48 hours after symptom onset
Key exclusion criteria	1. Patients who were clinically supposed to suffer from influenza, pneumonia of any cause, β-streptococcus tonsillitis, and other bacterial infections 2. Patients with serious or confusing underlying diseases including: bronchial asthma, peptic ulcer, diabetes mellitus, and allergic rhinitis 3. Immunocompromized or pregnant persons 4. Patients who were currently using antibiotics, systemic corticosteroids, immunosuppressants or anticoagulants 5. Patients who had taken NSAIDs or Chinese herbal medicines as cold remedies within 12 hours
Date of first enrolment	01/12/2002
Date of final enrolment	31/03/2004

Yoshida-Honmachi

Kyoto
606-8501
Japan

Kyoto University (Japan)
University/education

Yoshida-Honmachi
Sakyo-ku
Kyoto
606-8501
Japan

Charity

Suzuken Memorial Foundation (2002)

No information available

Uehara Memorial Foundation (2003)

No information available

Grant for Frontier Medicine from the Ministry of Education, Culture, Sports, Science and Technology, Japan (2002-2004)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2007		Yes	No