Dose-ranging study of SCH34117 in the treatment of patients with seasonal allergic rhinitis
| ISRCTN | ISRCTN32042139 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32042139 |
| Secondary identifying numbers | C98-001 |
- 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
MD 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | SCH34117 |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/04/1998 |
| Completion date | 01/06/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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
Sponsor information
Schering-Plough Research Institute (SPRI) (USA)
Industry
Industry
2015 Galloping Hill Road, K-15-4
Kenilworth
NJ 07033-0530
United States of America
| Website | http://www.schering-plough.com/rd/rd02_research.html |
|---|---|
"ROR" |
https://ror.org/02891sr49 |
Funders
Funder type
Industry
Schering-Plough Research Institute (SPRI) (USA)
No information available
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 05/08/2002 | Yes | No |
