Condition category
Respiratory
Date applied
20/12/2005
Date assigned
17/01/2006
Last edited
25/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Takashi Kawamura

ORCID ID

Contact details

Yoshida-Honmachi
Sakyo-ku
Kyoto
606-8501
Japan
+81 75 753 2411
kawax@kuhp.kyoto-u.ac.jp

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

The Great Cold Study 2

Study hypothesis

Loxoprofen, one of the Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), prolongs the recovery process of naturally-infected upper respiratory tract infections

Ethics approval

The Ethical Committee of Kyoto University Faculty of Medicine (No. 404, October 29, 2002)

Study design

Randomised double-blind placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Loxoprofen sodium

Primary outcome measures

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 trial start date

01/12/2002

Overall trial end date

31/03/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

170

Participant 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

Recruitment start date

01/12/2002

Recruitment end date

31/03/2004

Locations

Countries of recruitment

Japan

Trial participating centre

Yoshida-Honmachi
Kyoto
606-8501
Japan

Sponsor information

Organisation

Kyoto University (Japan)

Sponsor details

Yoshida-Honmachi
Sakyo-ku
Kyoto
606-8501
Japan
+81 75 753 7531
info@mail.adm.kyoto-u.ac.jp

Sponsor type

University/education

Website

http://www.kyoto-u.ac.jp/

Funders

Funder type

Charity

Funder name

Suzuken Memorial Foundation (2002)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Uehara Memorial Foundation (2003)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17675766

Publication citations

  1. Results

    Goto M, Kawamura T, Shimbo T, Takahashi O, Ando M, Miyaki K, Nohara T, Watanabe H, Suzuki I, Aono M, , Influence of loxoprofen use on recovery from naturally acquired upper respiratory tract infections: a randomized controlled trial., Intern. Med., 2007, 46, 15, 1179-1186.

Additional files

Editorial Notes