Dose-ranging study of SCH34117 in the treatment of patients with seasonal allergic rhinitis
| ISRCTN | ISRCTN32042139 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32042139 |
| Protocol serial number | C98-001 |
| Sponsor | Schering-Plough Research Institute (SPRI) (USA) |
| Funder | Schering-Plough Research Institute (SPRI) (USA) |
- Submission date
- 02/08/2002
- Registration date
- 02/08/2002
- Last edited
- 06/09/2007
- 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
Dr Heribert Staudinger
Scientific
Scientific
Medical officer
Schering-Plough Research Institute (SPRI)
2015 Galloping Hill Road, K-15-4
Kenilworth
NJ 07033-0530
United States of America
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Seasonal allergic rhinitis |
| Intervention | Patients randomly assigned once-daily (QD) SCH34117 at doses of 2.5, 5, 7.5, 10, or 20 mg versus placebo for two weeks. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | SCH34117 |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 1026 |
| Key inclusion criteria | Subjects 12 years or older with a two-year documented history of seasonal allergic rhinitis and otherwise in good health |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/04/1998 |
| Date of final enrolment | 01/06/1998 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Medical officer
Kenilworth
NJ 07033-0530
United States of America
NJ 07033-0530
United States of America
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 | 05/08/2002 | Yes | No |
