| March 15, 2007 |
| October 27, 2009 |
| July 2007 |
| November 2011 (final data collection date for primary outcome measure) |
| To characterize the difference in prepubescent growth velocity in children 3 to 9 years of age with PAR treated with triamcinolone acetonide (TAA) nasal spray (Nasacort AQ 110 μg) or placebo (Nasacort AQ placebo) for 12 months. [ Time Frame: This study will consist of a 4-6 month (120-180 days) baseline period, a 12-month (360 ± 5 days) baseline period, and a 2-month (60 ± 5 days) follow-up period. ] [ Designated as safety issue: Yes ] |
| To characterize the difference in prepubescent growth velocity during the 12-month treatment period in children 3 to 9 years of age with PAR treated with triamcinolone acetonide (TAA) nasal spray (NASACORT AQ 110 μg) or placebo (NASACORT AQ placebo) |
| Complete list of historical versions of study NCT00449072 on ClinicalTrials.gov Archive Site |
- To compare 24 hr urinary free cortisol levels and the cortisol/creatinine ratio in prepubertal subjects treated with TAA nasal spray vs placebo. [ Time Frame: This study will consist of a 4-month (120-180 days) baseline period, a 12-month (360 ± 5 days) baseline period, and a 2-month (60 ± 5 days) follow-up period. ] [ Designated as safety issue: Yes ]
- To assess the global efficacy of TAA nasal spray vs placebo as rated separately by the investigator and the subject (with the help of a parent/guardian/caregiver) during and at the end of the double-blind treatment period. [ Time Frame: This study will consist of a 4-6month (120-180 days) baseline period, a 12-month (360 ± 5 days) treatment period, and a 2-month (60 ± 5 days) follow-up period. ] [ Designated as safety issue: No ]
- To determine the rate of use of rescue medication with TAA nasal spray vs placebo during each phase of the study (baseline, double-blind & follow up) [ Time Frame: This study will consist of a 4-6month (120-180 days) baseline period, a 12-month (360 ± 5 days) treatment period, and a 2-month (60 ± 5 days) follow-up period. ] [ Designated as safety issue: No ]
- To determine the rate of treatment-emergent adverse events with TAA nasal spray vs placebo. [ Time Frame: This study will consist of a 4-6 month (120-180 days) baseline period. a 12-month (360 ± 5 days) baseline period, and a 2-month (60 ± 5 days) follow-up period. ] [ Designated as safety issue: Yes ]
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- To compare 24 hr urinary free cortisol levels and the cortisol/creatinine ratio in prepubertal subjects treated with TAA nasal spray vs placebo.
- To assess the global efficacy of TAA nasal spray vs placebo as rated separately by the investigator and the subject (with the help of a parent/guardian/caregiver) during and at the end of the double-blind treatment period.
- To determine the rate of use of rescue medication with TAA nasal spray vs placebo during each phase of the study (baseline, double-blind & follow up)
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| Study of Triamcinolone Acetonide on the Growth Velocity of Children, Ages 3 to 9, With Perennial Allergic Rhinitis (PAR) |
| A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel Group Study of the 12 Month Effect of Treatment With Once Daily Triamcinolone Acetonide (NASACORT® AQ Nasal Spray 110 μg) on the Growth Velocity of Children, 3 to 9 Years of Age, With Perennial Allergic Rhinitis (PAR) |
The primary objective of the study is to characterize the difference in prepubescent growth velocity in children 3 to 9 years of age with PAR treated with TAA nasal spray (NASACORT AQ 110 μg treatment group) or placebo (NASACORT AQ placebo group) for 12-months. |
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| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Rhinitis, Allergic, Perennial |
- Drug: triamcinolone acetonide
- Other: placebo
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- Active Comparator: triamcinolone acetonide (TAA) AQ 110 μg (one 55-μg actuation/nostril) administered intranasally qd in subjects 3 to 9 years of age
- Placebo Comparator: TAA AQ placebo (one actuation/nostril) administered intranasally qd in subjects 3 to 9 years of age
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| Recruiting |
| 408 |
| November 2011 |
| November 2011 (final data collection date for primary outcome measure) |
Inclusion criteria:
- Male subjects [3 years to ≤9 years + 0 days old] at Visit 1 and no older than [9 years + 120 days] at Visit 3; and, female subjects [3 years to ≤8 years + 0 days old] at Visit 1 and no older than [8 years + 120 days] at Visit 3: all sexually prepubertal (ie, Stage 1 of Tanner Classification of sexual maturity) at Visit 1 and Visit 3. A 5-day extension to the age upper bound would be permitted under certain circumstances to enable scheduling of Visits 1 and 3
- At least a one year history of PAR as assessed and documented by the investigator (with or without seasonal allergic rhinitis [SAR])
- Positive skin test (prick or intradermal) to a perennial allergen that is present in the subject's environment. A skin test is considered positive if the wheal produced by the allergen is equal to or greater than that caused by positive control (histamine) or is at least 3 mm (prick test) or 7 mm (intradermal test) greater than the wheal of negative control (saline). If a skin test cannot be performed, the radioallergosorbent test (RAST) will be used as an alternative. Documented historical skin testing or RAST performed during the past year will be acceptable
- Height within the 3rd and 97th percentiles at screening (Visit 1), Visit 2, and at randomization (Visit 3)
- Symptomatic (daily AM instantaneous total nasal symptom score is ≥4 out of 12) on any 4 out of the last 7 consecutive days immediately prior to and including the morning of Visit 3. Symptom ratings will be completed with the help of a parent/guardian/caregiver
- Written informed consent and ability of parent or legal guardian of the subject to give a written informed consent before any study related procedures. Subjects 7 years of age and older must provide a signed assent form
- Subjects must be toilet-trained
Exclusion criteria:
- Gross nasal anatomical deformities including large polyposis and marked deviated septum
- History of or current cataract or glaucoma
- History of hypersensitivity to the corticosteroids or to any excipient of the investigational product
- Subject is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
- Height, weight, or body mass index (BMI)-for-age below the 3rd or above the 97th percentile at Visits 1, 2, or 3
- Treatment with systemic corticosteroids (oral, intravenous, intramuscular, or intra-articular) within 3 months prior to Visit 1
- Treatment with systemic corticosteroids for >2 courses received up to 1 year before Visit 1 is exclusionary. Up to 2 courses of systemic corticosteroids each course not exceeding 14 days up to 1 year before Visit 1 is allowed.
- Treatment with inhaled, intranasal, or high potency topical corticosteroid exposure within 6 weeks prior to Visit 1. Mild asthma will be well-controlled and without the use of inhaled corticosteroids within 6 weeks before screening (Visit 1).
- Immunotherapy, except stable (≥1 month) maintenance schedule before Visit 1.
- Treatment with any substance before Visit 1 that may affect growth velocity and/or linear growth, such as, but not be limited to methylphenidate hydrochloride, thyroid hormone, growth hormone, anabolic steroids, calcitonin, estrogens, progestins, bisphosphonates, anticonvulsants, or phosphate-binding antacids
- Treatment with any investigational product or device in the 30 days before Visit 1 or at any time throughout the duration of this trial (Visit 1 through Visit 11).
- Bone age as assessed by xray of the left hand and wrist that is outside +/- 1.5 years of subjects chronological age at Visit 2. Right hand and wrist will be radiographed in the event of bone injury to the left hand or wrist.
- Unresolved upper respiratory tract infection, sinus infection or nasal candidiasis (i.e., symptomatic or under treatment)within the last 2 weeks before Visit 3.
- Subjects or parent/guardian/caregiver unable to demonstrate correct administration of the investigational product at Visit 1.
- Concomitant disease other than PAR which could interfere with the study procedures or outcomes as determined by the investigator.
- History of hospitalization due to asthma within 1 year before screening (Visit 1).
- Abnormal 24-hour urinary free cortisol level assessed at screening (Visit 2).
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
| Both |
| 3 Years to 9 Years |
| No |
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| United States |
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| NCT00449072 |
| Study Director, sanofi-aventis |
| XRG5029C_3503 |
| Sanofi-Aventis |
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| Study Director: |
Tara Semanchik, MBA |
Sanofi-Aventis |
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| Sanofi-Aventis |
| October 2009 |