A Study of Efficacy of New Doses of Xolair to Protect From Allergen Challenge in Groups of Asthma Patients Defined by IgE Levels
Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00624832
Collaborator
Genentech, Inc. (Industry), Tanox (Industry)
60
6
4
11
10
0.9
Study Details
Study Description
Brief Summary
This study was intended to demonstrate that patients with standard and high immunoglobulin E (IgE) levels can be protected from allergen induced broncho-constriction by Xolair
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-controlled Study to Demonstrate the Efficacy of Xolair in an Allergen Bronchoprovocation Study in Asthmatic Populations Defined by Serum IgE Concentrations
Study Start Date
:
Feb 1, 2008
Actual Primary Completion Date
:
Jan 1, 2009
Actual Study Completion Date
:
Jan 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight. |
Drug: Xolair
Xolair (Omalizumab) dose: 2 x 450 mg, 2 x 525 mg or 2 x 600 mg; subcutaneous injection;
|
| Experimental: Xolair (Immunoglobulin E (IgE) = 700-2000 IU/mL) Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight. |
Drug: Xolair
Xolair (Omalizumab) dose: 2 x 450 mg, 2 x 525 mg or 2 x 600 mg; subcutaneous injection;
|
| Experimental: Xolair (Immunoglobulin E (IgE) = 301-699 IU/mL) Patients with screening Immunoglobulin E (IgE) levels = 301- 699 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight. |
Drug: Xolair
Xolair (Omalizumab) dose: 2 x 450 mg, 2 x 525 mg or 2 x 600 mg; subcutaneous injection;
|
| Placebo Comparator: Placebo By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks. |
Drug: Placebo
Matching placebo of Xolair (omalizumab), by subcutaneous injection of a solution with a concentration of 125 mg/mL in a supine position.
|
Outcome Measures
Primary Outcome Measures
- Early Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients [Week 8, Week 16]
The EAR was defined as the maximum percent drop in forced expiratory volume in one second (FEV1) in the first 30 minutes after the challenge: EAR = 100* [ FEV1 (0) - Minimum FEV1 (10, 15, 30 min)] / FEV1 (0). For FEV1 (0), the "best post saline (Control) FEV1" was used. The EAR was analyzed using a linear (ANCOVA) model with a fixed effect for treatment groups and the EAR from the baseline challenge was used as a covariate.
Secondary Outcome Measures
- Late Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients [Week 0, Week 8 and Week 16]
Late-phase allergic response (LAR) was only determined for those patients who had an LAR >= 15% at baseline allergen bronchoprovocation testing. For Forced Expiratory Volume, FEV1 (0), the "best post saline (Control) FEV1" was used. LAR (%) = 100*[FEV1 (0) - Minimum FEV1 (3-8h)]/FEV1 (0).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Male and female adult patients, body weight between 40-150 kg aged 18-65 years (inclusive)
-
Patients diagnosed with asthma with Forced Expiratory Volume (FEV1) ≥65% of the predicted normal value for the patient
-
Positive skin prick test to a specific allergen
-
Patients had to demonstrate a Provocative Dose 20% FEV1 decline (PD20) response to an aeroallergen in the graded allergen bronchoprovocation testing (ABP) at screening
Exclusion Criteria:
-
Current active smokers
-
Patients who have been hospitalized or had emergency treatment for an asthma attack in the 12 months prior to study start
-
History of bleeding disorders
-
History of drug allergy
-
Pregnant women or nursing mothers
-
Females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception (surgical contraception or double barrier methods (to be continued for at least two months following last dose) are acceptable).
-
Sexually active males who have not been sterilized and are not using a condom
-
History of immunocompromise, including a positive HIV
-
A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
-
History of drug or alcohol abuse within 12 months of study start
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigator Site | Berlin | Germany | ||
| 2 | Novartis Investigator Site | Frankfurt | Germany | ||
| 3 | Novartis Investigator Site | Munich | Germany | ||
| 4 | Novartis Investigator Site | Groningen | Netherlands | ||
| 5 | Novartis Investigator Site | Bloemfontein | South Africa | ||
| 6 | Novartis Investigator Site | Durban | South Africa |
Sponsors and Collaborators
- Novartis
- Genentech, Inc.
- Tanox
Investigators
- Principal Investigator: Novartis, Novartis investigator site
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00624832
Other Study ID Numbers:
- CIGE025A2210
First Posted:
Feb 27, 2008
Last Update Posted:
Apr 19, 2011
Last Verified:
Apr 1, 2011
Keywords provided by ,
,
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) | Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) | Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) | Placebo Comparator |
|---|---|---|---|---|
| Arm/Group Description | Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight. | Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight. | Patients with screening Immunoglobulin E (IgE) levels = 301- 699 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight. | By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks. |
| Period Title: Overall Study | ||||
| STARTED | 18 | 16 | 10 | 16 |
| COMPLETED | 16 | 15 | 10 | 15 |
| NOT COMPLETED | 2 | 1 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) | Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) | Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) | Placebo Comparator | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight. | Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight. | Patients with screening Immunoglobulin E (IgE) levels = 301- 699 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight. | By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks. | Total of all reporting groups |
| Overall Participants | 18 | 16 | 10 | 16 | 60 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
36
(11.9)
|
29
(11.0)
|
26
(6.0)
|
34
(10.4)
|
32
(10.9)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
5
27.8%
|
10
62.5%
|
4
40%
|
7
43.8%
|
26
43.3%
|
| Male |
13
72.2%
|
6
37.5%
|
6
60%
|
9
56.3%
|
34
56.7%
|
Outcome Measures
| Title | Early Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients |
|---|---|
| Description | The EAR was defined as the maximum percent drop in forced expiratory volume in one second (FEV1) in the first 30 minutes after the challenge: EAR = 100* [ FEV1 (0) - Minimum FEV1 (10, 15, 30 min)] / FEV1 (0). For FEV1 (0), the "best post saline (Control) FEV1" was used. The EAR was analyzed using a linear (ANCOVA) model with a fixed effect for treatment groups and the EAR from the baseline challenge was used as a covariate. |
| Time Frame | Week 8, Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety and Pharmacodynamic (PD) population. Although all patients had baseline EAR not all of them had a value determined for week 8 and 16 reducing the number evaluable for analysis particularly at week 8. Patients of first 2 Xolair groups received placebo treatment were pooled in one placebo group for analysis. No analysis on third Xolair groups. |
| Arm/Group Title | Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) | Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) | Placebo Comparator |
|---|---|---|---|
| Arm/Group Description | Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight. | Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight. | By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks. |
| Measure Participants | 18 | 16 | 16 |
| Week 8 (n=12, 12, 13) |
9.3
(3.97)
|
5.6
(2.07)
|
23.1
(3.57)
|
| Week 16 (n=14, 15, 15) |
11.8
(3.81)
|
5.1
(2.02)
|
20.0
(2.43)
|
| Title | Late Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients |
|---|---|
| Description | Late-phase allergic response (LAR) was only determined for those patients who had an LAR >= 15% at baseline allergen bronchoprovocation testing. For Forced Expiratory Volume, FEV1 (0), the "best post saline (Control) FEV1" was used. LAR (%) = 100*[FEV1 (0) - Minimum FEV1 (3-8h)]/FEV1 (0). |
| Time Frame | Week 0, Week 8 and Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety and Pharmacodynamic (PD) population. Although all patients had baseline EAR not all of them had a value determined for week 8 and 16 reducing the number evaluable for analysis particularly at week 8. Patients of first 2 Xolair groups received placebo treatment were pooled in one placebo group for analysis. No analysis on third Xolair groups. |
| Arm/Group Title | Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) | Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) | Placebo Comparator |
|---|---|---|---|
| Arm/Group Description | Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight. | Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight. | By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks. |
| Measure Participants | 18 | 16 | 16 |
| Week 0 (n=8, 3, 5) |
22.5
(6.12)
|
25.7
(12.62)
|
27.4
(7.27)
|
| Week 8 (n=6, 1, 3) |
5.3
(12.13)
|
-3.5
(0.0)
|
19.1
(13.42)
|
| Week 16 (n=7, 2, 4) |
0.23
(7.109)
|
1.5
(1.53)
|
12.3
(7.09)
|
Adverse Events
| Time Frame | 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Xolair (IgE= 30- 300 IU/mL) | Xolair (IgE= 700- 2000 IU/mL) | Xolair (IgE= 301- 699 IU/mL) | Placebo Comparator | ||||
| Arm/Group Description | Patients with screening IgE levels= 30-300 IU/mL. Participants received subcutaneous injections of Xolair(Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight. | Patients with screening IgE levels= 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair(Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight. | Patients with screening IgE levels= 301- 699 IU/mL. Participants received subcutaneous injections of Xolair(Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight. | Placebo comparator | ||||
All Cause Mortality |
||||||||
| Xolair (IgE= 30- 300 IU/mL) | Xolair (IgE= 700- 2000 IU/mL) | Xolair (IgE= 301- 699 IU/mL) | Placebo Comparator | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Xolair (IgE= 30- 300 IU/mL) | Xolair (IgE= 700- 2000 IU/mL) | Xolair (IgE= 301- 699 IU/mL) | Placebo Comparator | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/18 (5.6%) | 1/16 (6.3%) | 0/10 (0%) | 0/16 (0%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Malignant melanoma | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 0/16 (0%) | ||||
| Papilloma | 1/18 (5.6%) | 0/16 (0%) | 0/10 (0%) | 0/16 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Xolair (IgE= 30- 300 IU/mL) | Xolair (IgE= 700- 2000 IU/mL) | Xolair (IgE= 301- 699 IU/mL) | Placebo Comparator | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/18 (50%) | 15/16 (93.8%) | 6/10 (60%) | 12/16 (75%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Lymphadenopathy | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 0/16 (0%) | ||||
| Cardiac disorders | ||||||||
| Tachycardia | 0/18 (0%) | 0/16 (0%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Ear and labyrinth disorders | ||||||||
| Ear pain | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 0/16 (0%) | ||||
| Vertigo | 2/18 (11.1%) | 0/16 (0%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Eye disorders | ||||||||
| Conjunctivitis | 1/18 (5.6%) | 0/16 (0%) | 1/10 (10%) | 2/16 (12.5%) | ||||
| Conjunctivitis allergic | 0/18 (0%) | 0/16 (0%) | 2/10 (20%) | 0/16 (0%) | ||||
| Eye irritation | 1/18 (5.6%) | 0/16 (0%) | 0/10 (0%) | 0/16 (0%) | ||||
| Eye pruritus | 1/18 (5.6%) | 0/16 (0%) | 0/10 (0%) | 0/16 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal pain | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 0/16 (0%) | ||||
| Diarrhoea | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Dry mouth | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 0/16 (0%) | ||||
| Dyspepsia | 0/18 (0%) | 0/16 (0%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Gastrointestinal disorder | 0/18 (0%) | 0/16 (0%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Nausea | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Toothache | 1/18 (5.6%) | 0/16 (0%) | 0/10 (0%) | 0/16 (0%) | ||||
| Vomiting | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 0/16 (0%) | ||||
| General disorders | ||||||||
| Fatigue | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 2/16 (12.5%) | ||||
| Infusion site erythema | 1/18 (5.6%) | 2/16 (12.5%) | 0/10 (0%) | 0/16 (0%) | ||||
| Infusion site haematoma | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 0/16 (0%) | ||||
| Infusion site induration | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 0/16 (0%) | ||||
| Infusion site irritation | 0/18 (0%) | 0/16 (0%) | 1/10 (10%) | 0/16 (0%) | ||||
| Infusion site swelling | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 0/16 (0%) | ||||
| Infusion site warmth | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 0/16 (0%) | ||||
| Injection site pain | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Injection site swelling | 1/18 (5.6%) | 0/16 (0%) | 0/10 (0%) | 2/16 (12.5%) | ||||
| Pyrexia | 0/18 (0%) | 0/16 (0%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Immune system disorders | ||||||||
| Seasonal allergy | 0/18 (0%) | 0/16 (0%) | 2/10 (20%) | 0/16 (0%) | ||||
| Infections and infestations | ||||||||
| Bronchitis | 0/18 (0%) | 0/16 (0%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Eczema infected | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 0/16 (0%) | ||||
| Herpes virus infection | 1/18 (5.6%) | 1/16 (6.3%) | 0/10 (0%) | 0/16 (0%) | ||||
| Infectious mononucleosis | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 0/16 (0%) | ||||
| Laryngitis | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 0/16 (0%) | ||||
| Nasopharyngitis | 3/18 (16.7%) | 5/16 (31.3%) | 1/10 (10%) | 4/16 (25%) | ||||
| Oral herpes | 0/18 (0%) | 2/16 (12.5%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Oral infection | 0/18 (0%) | 0/16 (0%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Pharyngitis | 0/18 (0%) | 0/16 (0%) | 1/10 (10%) | 0/16 (0%) | ||||
| Pilonidal cyst | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 0/16 (0%) | ||||
| Rhinitis | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Sinusitis | 0/18 (0%) | 0/16 (0%) | 0/10 (0%) | 2/16 (12.5%) | ||||
| Tinea pedis | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 0/16 (0%) | ||||
| Tonsillitis | 0/18 (0%) | 0/16 (0%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Upper respiratory tract infection | 0/18 (0%) | 0/16 (0%) | 1/10 (10%) | 2/16 (12.5%) | ||||
| Urinary tract infection | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Viral infection | 1/18 (5.6%) | 0/16 (0%) | 0/10 (0%) | 0/16 (0%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Excoriation | 0/18 (0%) | 0/16 (0%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Road traffic accident | 0/18 (0%) | 0/16 (0%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Sunburn | 0/18 (0%) | 0/16 (0%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Tooth injury | 0/18 (0%) | 0/16 (0%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Wound complication | 1/18 (5.6%) | 0/16 (0%) | 0/10 (0%) | 0/16 (0%) | ||||
| Investigations | ||||||||
| Blood pressure diastolic increased | 0/18 (0%) | 0/16 (0%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Blood pressure systolic increased | 0/18 (0%) | 0/16 (0%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Back pain | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 0/16 (0%) | ||||
| Myosclerosis | 0/18 (0%) | 0/16 (0%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Pain in extremity | 0/18 (0%) | 0/16 (0%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Nervous system disorders | ||||||||
| Dizziness | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 0/16 (0%) | ||||
| Dysgeusia | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 0/16 (0%) | ||||
| Headache | 4/18 (22.2%) | 5/16 (31.3%) | 1/10 (10%) | 3/16 (18.8%) | ||||
| Psychiatric disorders | ||||||||
| Sleep disorder | 0/18 (0%) | 0/16 (0%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Reproductive system and breast disorders | ||||||||
| Dysmenorrhoea | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Asthma | 0/18 (0%) | 0/16 (0%) | 0/10 (0%) | 2/16 (12.5%) | ||||
| Bronchial obstruction | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 0/16 (0%) | ||||
| Bronchospasm | 0/18 (0%) | 0/16 (0%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Cough | 1/18 (5.6%) | 0/16 (0%) | 1/10 (10%) | 2/16 (12.5%) | ||||
| Dyspnoea | 1/18 (5.6%) | 0/16 (0%) | 1/10 (10%) | 1/16 (6.3%) | ||||
| Epistaxis | 0/18 (0%) | 0/16 (0%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Oropharyngeal pain | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 2/16 (12.5%) | ||||
| Productive cough | 0/18 (0%) | 0/16 (0%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Rhinitis allergic | 0/18 (0%) | 0/16 (0%) | 0/10 (0%) | 2/16 (12.5%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Dermatitis | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 0/16 (0%) | ||||
| Dermographism | 0/18 (0%) | 0/16 (0%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Neurodermatitis | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 0/16 (0%) | ||||
| Photosensitivity reaction | 0/18 (0%) | 0/16 (0%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Pruritus | 0/18 (0%) | 1/16 (6.3%) | 0/10 (0%) | 1/16 (6.3%) | ||||
| Vascular disorders | ||||||||
| Hypertension | 1/18 (5.6%) | 0/16 (0%) | 0/10 (0%) | 0/16 (0%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Novartis Pharmaceuticals |
| Phone | 862-778-8300 |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00624832
Other Study ID Numbers:
- CIGE025A2210
First Posted:
Feb 27, 2008
Last Update Posted:
Apr 19, 2011
Last Verified:
Apr 1, 2011