Delayed recovery from naturally infected upper respiratory tract infections by loxoprofen: a randomized controlled trial
| ISRCTN | ISRCTN71443934 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71443934 |
| Protocol serial number | N/A |
| Sponsor | Kyoto University (Japan) |
| Funders | Suzuken Memorial Foundation (2002), Uehara Memorial Foundation (2003), Grant for Frontier Medicine from the Ministry of Education, Culture, Sports, Science and Technology, Japan (2002-2004) |
- Submission date
- 20/12/2005
- Registration date
- 17/01/2006
- Last edited
- 25/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Takashi Kawamura
Scientific
Scientific
Yoshida-Honmachi
Sakyo-ku
Kyoto
606-8501
Japan
| Phone | +81 75 753 2411 |
|---|---|
| kawax@kuhp.kyoto-u.ac.jp |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind placebo-controlled study |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Loxoprofen sodium |
| Primary outcome measure(s) |
The interval, in days, from the onset of any URTI symptom to the disappearance of all URTI symptoms |
| Key secondary outcome measure(s) |
Severity of the URTI symptoms |
| Completion date | 31/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Japan
Study participating centre
Yoshida-Honmachi
Kyoto
606-8501
Japan
606-8501
Japan
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2007 | Yes | No |
