Once-Daily Investigational Nasal Spray In Adults And Adolescents With Vasomotor Rhinitis
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00118703
First received: July 1, 2005
Last updated: June 21, 2012
Last verified: March 2011
| Tracking Information | |||||
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| First Received Date ICMJE | July 1, 2005 | ||||
| Last Updated Date | June 21, 2012 | ||||
| Start Date ICMJE | July 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Mean change from baseline over the entire treatment period in daily, reflective total nasal symptom scores. Subjects complete diaries twice daily (every 12 hours) reporting the severity of their VMR (vasomotor rhinitis) symptoms. | ||||
| Original Primary Outcome Measures ICMJE |
Mean change from baseline in daily, reflective total nasal symptom scores | ||||
| Change History | Complete list of historical versions of study NCT00118703 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous total nasal symptom scores. The subject completes this overall evaluation of response to therapy during the last clinic visit. | ||||
| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Once-Daily Investigational Nasal Spray In Adults And Adolescents With Vasomotor Rhinitis | ||||
| Official Title ICMJE | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 Years of Age and Older) With Vasomotor Rhinitis | ||||
| Brief Summary | The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with vasomotor rhinitis (VMR). |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: GW685698X
Other Name: GW685698X |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 350 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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| Gender | Both | ||||
| Ages | 12 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Canada, Czech Republic, Germany, Puerto Rico, Romania | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00118703 | ||||
| Other Study ID Numbers ICMJE | FFR30007 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | GlaxoSmithKline | ||||
| Study Sponsor ICMJE | GlaxoSmithKline | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | March 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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