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Trial record 13 of 37 for:    " April 15, 2009":" May 15, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

A Phase I Multiple Dose Pharmacokinetic Study of Nevirapine Extended Release (XR) in HIV-1 Infected Children.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00905489
Recruitment Status : Completed
First Posted : May 20, 2009
Results First Posted : May 7, 2014
Last Update Posted : January 7, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Nevirapine Immediate Release (IR)
Drug: Nevirapine Extended Release (XR)
Enrollment 85
Recruitment Details Multicenter Phase I study in Botswana, Germany, South Africa and the United States.
Pre-assignment Details There was only one treatment group and no randomization process. Overall, 90 pediatric patients were enrolled. Five patients were not entered and 85 patients entered the study. Patients were stratified to the following three age groups: (26 in the 3 - <6 year age group, 26 in the 6 - < 12 year age group and 33 in the 12 - < 18 year age group).
Arm/Group Title Total.
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All patients enrolled in study.

All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).

Period Title: Pharmaco-kinetic (PK) Phase
Started 85
Completed 80
Not Completed 5
Reason Not Completed
Protocol Violation             2
Other reason not defined above             3
Period Title: Optional Extension Phase (OEP)
Started 40 [1]
Completed 39
Not Completed 1
Reason Not Completed
Adverse Event             1
[1]
Includes only subjects who chose to continue trt with nevirapine XR after completing the PK phase.
Arm/Group Title Total.
Hide Arm/Group Description

All patients enrolled in study.

All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).

Overall Number of Baseline Participants 85
Hide Baseline Analysis Population Description
Full analysis set (FAS): All patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 85 participants
9.3  (4.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants
Female
47
  55.3%
Male
38
  44.7%
1.Primary Outcome
Title Trough Cpre,N.
Hide Description

Trough Nevirapine concentration immediately prior to the next scheduled dose. Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.

The measure of dispersion presented is the coefficient of variation (%) rather than the geometric coefficient of variation.

Time Frame Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR
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PK analysis set (PKS): This patient set includes all patients in the Full Analysis Set (FAS) set that have no protocol violations excluding them from PK analyses.
Arm/Group Title NVP XR NVP IR
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Nevirapine XR (extended release)
Nevirapine IR (immediate release)
Overall Number of Participants Analyzed 74 78
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: (ng/mL/mg)
15.47
(64.34%)
16.66
(75.03%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NVP XR, NVP IR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0080
Comments [Not Specified]
Method Mixed Models Analysis
Comments Adjusted geometric means are estimated from the mixed model for intra-individual comparison.
Method of Estimation Estimation Parameter Ratio NVP XR: NVP IR (%)
Estimated Value 91.20
Confidence Interval (2-Sided) 90%
83.47 to 99.64
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.05
Estimation Comments [Not Specified]
2.Secondary Outcome
Title AUCt,ss
Hide Description

Area under the concentration-time curve of the Nevirapine (NVP) in plasma at steady state over the time dosing interval τ.

All patients received nevirapine IR for 10 days prior to collection of 12-hour Area Under the Curve (AUC) data. Then, all patients were switched to nevirapine XR for 9 days prior to collection of 24-hour AUC data. The treatments of IR and XR are summarized separately using geometric means and geometric coefficients of variation.

For NVP IR AUC measured over hours: 0,1,2,3,4,8 and 12, For NVP XR AUC measured over hours: 0,1,2,3,4,8,10,12 and 24.

Time Frame Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR
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Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.
Arm/Group Title NVP XR NVP IR
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Nevirapine XR (extended release)
Nevirapine IR (immediate release)
Overall Number of Participants Analyzed 45 49
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/ml
200mg NVP XR QD (175-249 mg IR/day), n=23/22
99300
(37.7%)
57900
(45.7%)
300mg NVP XR QD (250-349 mg IR/day), n=11/12
144000
(50.1%)
58100
(35.0%)
400mg NVP XR QD (≥350 mg IR/day), n=11/15
108000
(60.7%)
73400
(39.8%)
3.Secondary Outcome
Title Cmin,ss (for IR and XR Formulations by Nevirapine XR Dose Group)
Hide Description Minimum measured concentration of the Nevirapine in plasma at steady state over the time dosing interval τ by nevirapine XR dose group Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 21.
Time Frame Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR
Hide Outcome Measure Data
Hide Analysis Population Description
Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.
Arm/Group Title NVP XR NVP IR
Hide Arm/Group Description:
Nevirapine XR (extended release)
Nevirapine IR (immediate release)
Overall Number of Participants Analyzed 45 49
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
200 mg XR QD (175-249 mg IR/day), n=23,22
3090
(37.9%)
3280
(57.6%)
300 mg XR QD (250-349 mg IR/day), n=11,12
4160
(62.6%)
3620
(34.7%)
400 mg XR QD (≥350 mg IR/day), n=11,15
3410
(63.0%)
4960
(39.1%)
4.Secondary Outcome
Title Cmax,ss (for IR and XR Formulations by Nevirapine XR Dose Group)
Hide Description Maximum measured concentration of the Nevirapine in plasma at steady state over the time dosing interval τ Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.
Time Frame Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR
Hide Outcome Measure Data
Hide Analysis Population Description
Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.
Arm/Group Title NVP XR NVP IR
Hide Arm/Group Description:
Nevirapine XR (extended release)
Nevirapine IR (immediate release)
Overall Number of Participants Analyzed 45 49
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
200 mg XR QD (175-249 mg IR/day), n=23,22
5350
(43.1%)
6850
(52.6%)
300 mg XR QD (250-349 mg IR/day), n=11,12
7970
(53.5%)
6580
(31.4%)
400 mg XR QD (≥350 mg IR/day), n=11,15
5890
(50.5%)
7790
(43.2%)
5.Secondary Outcome
Title Ratio Cmax,ss/Cmin,ss
Hide Description Ratio of (maximum measured concentration of the Nevirapine in plasma at steady state over the time dosing interval τ)/(minimum measured concentration of the analyte in plasma at steady state over the time dosing interval τ) Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.
Time Frame Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR
Hide Outcome Measure Data
Hide Analysis Population Description
Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.
Arm/Group Title NVP XR NVP IR
Hide Arm/Group Description:
Nevirapine XR (extended release)
Nevirapine IR (immediate release)
Overall Number of Participants Analyzed 45 49
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
200 mg XR QD (175-249 mg IR/day), n=23,22
1.73
(23.7%)
2.09
(32.3%)
300 mg XR QD (250-349 mg IR/day), n=11,12
1.91
(39.4%)
1.82
(17.8%)
400 mg XR QD (≥350 mg IR/day), n=11,15
1.73
(21.8%)
1.57
(21.1%)
6.Secondary Outcome
Title %PTF
Hide Description Percentage peak-trough Nevirapine fluctuation, % fluctuation (degree of peak to trough fluctuation) Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.
Time Frame Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR
Hide Outcome Measure Data
Hide Analysis Population Description
Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.
Arm/Group Title NVP XR NVP IR
Hide Arm/Group Description:
Nevirapine XR (extended release)
Nevirapine IR (immediate release)
Overall Number of Participants Analyzed 45 49
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: percentage fluctuation
200 mg XR QD (175-249 mg IR/day), n=23,22
49.7
(47.3%)
67.9
(49.8%)
300 mg XR QD (250-349 mg IR/day), n=11,12
54.6
(61.1%)
59.1
(29.4%)
400 mg XR QD (≥350 mg IR/day), n=11,15
51.0
(47.6%)
41.5
(55.7%)
7.Secondary Outcome
Title Tmax,ss
Hide Description

Time from dosing to the maximum concentration of the Nevirapine in plasma at steady state over the time dosing interval τ Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.

The standard deviation is actually the coefficient of variation.

Time Frame Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR
Hide Outcome Measure Data
Hide Analysis Population Description
Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.
Arm/Group Title NVP XR NVP IR
Hide Arm/Group Description:
Nevirapine XR (extended release)
Nevirapine IR (immediate release)
Overall Number of Participants Analyzed 45 49
Mean (Standard Deviation)
Unit of Measure: hours
200 mg XR QD (175-249 mg IR/day), n=23,22 6.34  (104) 2.46  (57.9)
300 mg XR QD (250-349 mg IR/day), n=11,12 7.28  (121) 2.49  (50.4)
400 mg XR QD (≥350 mg IR/day), n=11,15 5.73  (129) 4.41  (94.2)
8.Secondary Outcome
Title CL/F,ss
Hide Description Apparent clearance of the Nevirapine in the plasma after extravascular administration at steady-state Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.
Time Frame Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR
Hide Outcome Measure Data
Hide Analysis Population Description
Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.
Arm/Group Title NVP XR NVP IR
Hide Arm/Group Description:
Nevirapine XR (extended release)
Nevirapine IR (immediate release)
Overall Number of Participants Analyzed 45 49
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/h
200 mg XR QD (175-249 mg IR/day), n=23,22
2010
(37.7%)
1780
(44.3%)
300 mg XR QD (250-349 mg IR/day), n=11,12
2080
(50.1%)
2240
(32.9%)
400 mg XR QD (≥350 mg IR/day), n=11,15
3700
(60.7%)
2640
(39.3%)
9.Secondary Outcome
Title Cavg
Hide Description Average measured concentration of the Nevirapine in plasma at steady state Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.
Time Frame Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR
Hide Outcome Measure Data
Hide Analysis Population Description
Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.
Arm/Group Title NVP XR NVP IR
Hide Arm/Group Description:
Nevirapine XR (extended release)
Nevirapine IR (immediate release)
Overall Number of Participants Analyzed 45 49
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
200 mg XR QD (175-249 mg IR/day), n=23,22
4140
(37.7%)
4820
(45.7%)
300 mg XR QD (250-349 mg IR/day), n=11,12
6010
(50.1%)
4840
(35.0%)
400 mg XR QD (≥350 mg IR/day), n=11,15
4510
(60.7%)
6120
(39.8%)
10.Secondary Outcome
Title Efficacy: Patients Maintaining a VL < 50 Copies/mL
Hide Description Patients maintaining a viral load < 50 copies/mL at Day 22.
Time Frame Day 22
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Full analysis set including patients with available viral load data at day 22
Arm/Group Title 3-<6 yr 6-<12 yr 12-<18 yr Total.
Hide Arm/Group Description:
Patients 3 to < 6 years old.
Patients 6 to < 12 years old.
Patients 12 to < 18 years old.
All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).
Overall Number of Participants Analyzed 25 23 31 79
Measure Type: Number
Unit of Measure: percentage of patients
96.0 100.0 100.0 98.7
11.Secondary Outcome
Title Efficacy: Patients Maintaining a VL < 400 Copies/mL
Hide Description Patients maintaining a viral load < 400 copies/mL at Day 22
Time Frame Day 22
Hide Outcome Measure Data
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Full analysis set including patients with available viral load data at day 22
Arm/Group Title 3-<6 yr 6-<12 yr 12-<18 yr Total.
Hide Arm/Group Description:
Patients 3 to < 6 years old.
Patients 6 to < 12 years old.
Patients 12 to < 18 years old.
All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).
Overall Number of Participants Analyzed 25 23 31 79
Measure Type: Number
Unit of Measure: percentage of patients
100.0 100.0 100.0 100.0
12.Secondary Outcome
Title Change From Baseline in Mean CD4+ Count (Absolute)
Hide Description Change in mean CD4+ count (absolute) from baseline to Day 22 and from baseline to Week 24.
Time Frame Baseline, Day 22 and week 24
Hide Outcome Measure Data
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PK Analysis set: This patient set includes all patients in the Full Analysis Set (FAS) that have no protocol violations excluding them from PK analysis.
Arm/Group Title 3-<6 yr 6-<12 yr 12-<18 yr
Hide Arm/Group Description:
Patients 3 to < 6 years old.
Patients 6 to < 12 years old.
Patients 12 to < 18 years old.
Overall Number of Participants Analyzed 24 24 31
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
Day 22 -115.6  (320.5) 24.2  (184.8) 60.3  (171.2)
Week 24 (n=8;10;9) -214.5  (397.5) -51.2  (179.4) 31.1  (66.4)
13.Secondary Outcome
Title Percentage Change From Baseline in Mean CD4+ Count
Hide Description ((Day 22 value-Baseline value)/Baseline value)*100. ((Week 24 value-Baseline value)/Baseline value)*100.
Time Frame Baseline to day 22 and baseline to week 24
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Optional Extension Phase Treated Set (OEP TS), all patients that complete PK phase and enroll in Extension phase, and had available data at either day 22 or week 24.
Arm/Group Title 3-<6 yr 6-<12 yr 12-<18 yr
Hide Arm/Group Description:
Patients 3 to < 6 years old.
Patients 6 to < 12 years old.
Patients 12 to < 18 years old.
Overall Number of Participants Analyzed 24 24 31
Mean (Standard Deviation)
Unit of Measure: percentage change
Day 22 -2.1  (6.7) -0.0  (2.5) 0.5  (3.6)
Week 24 (n=8, 10, 9) -2.1  (4.0) -2.1  (3.4) -1.0  (2.9)
14.Secondary Outcome
Title Efficacy: Patients Maintaining a VL < 50 Copies/mL at Week 24 of Optional Extension Phase
Hide Description Patients maintaining a viral load < 50 copies/mL at week 24 (approximately 168 days) of Optional Extension Phase (OEP).
Time Frame week 24
Hide Outcome Measure Data
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Full analysis set including patients with available viral load data at week 24
Arm/Group Title 3-<6 yr 6-<12 yr 12-<18 yr Total.
Hide Arm/Group Description:
Patients 3 to < 6 years old.
Patients 6 to < 12 years old.
Patients 12 to < 18 years old.
All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).
Overall Number of Participants Analyzed 8 10 9 27
Measure Type: Number
Unit of Measure: percentage of patients
100.0 100.0 100.0 100.0
15.Secondary Outcome
Title Efficacy: Patients Maintaining a VL < 400 Copies/mL in Optional Extension Phase
Hide Description Patients maintaining a viral load < 400 copies/mL at week 24 of the Optional Extension Phase (OEP)
Time Frame week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set including patients with available viral load data at week 24
Arm/Group Title 3-<6 yr 6-<12 yr 12-<18 yr Total.
Hide Arm/Group Description:
Patients 3 to < 6 years old.
Patients 6 to < 12 years old.
Patients 12 to < 18 years old.
All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).
Overall Number of Participants Analyzed 8 10 9 27
Measure Type: Number
Unit of Measure: percentage of patients
100.0 100.0 100.0 100.0
16.Other Pre-specified Outcome
Title Efficacy: Patients Maintaining a VL < 50 Copies/mL at Last Available Visit
Hide Description Patients maintaining a viral load < 50 copies/mL at the last available visit
Time Frame Last available visit, up to 155 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Optional Extension Phase Treated Set (OEP TS), all patients that complete PK phase and enroll in Extension phase with VL data available
Arm/Group Title 3-<6 yr 6-<12 yr 12-<18 yr Total.
Hide Arm/Group Description:
Patients 3 to < 6 years old.
Patients 6 to < 12 years old.
Patients 12 to < 18 years old.
All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).
Overall Number of Participants Analyzed 12 16 12 40
Measure Type: Number
Unit of Measure: percentage of patients
100.0 100.0 100.0 100.0
Time Frame From the first drug administration until 14 days after the last drug administration, up to 157 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Total.
Hide Arm/Group Description

All patients enrolled in study.

All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).

All-Cause Mortality
Total.
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Total.
Affected / at Risk (%)
Total   3/85 (3.53%) 
Infections and infestations   
Coxsackie viral infection  1  1/85 (1.18%) 
Pneumonia  1  1/85 (1.18%) 
Injury, poisoning and procedural complications   
Concussion  1  1/85 (1.18%) 
Fall  1  1/85 (1.18%) 
Skin and subcutaneous tissue disorders   
Dermatitis  1  1/85 (1.18%) 
Surgical and medical procedures   
Tonsillectomy  1  1/85 (1.18%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Total.
Affected / at Risk (%)
Total   56/85 (65.88%) 
Eye disorders   
Conjunctivitis  1  11/85 (12.94%) 
Gastrointestinal disorders   
Diarrhoea  1  5/85 (5.88%) 
Vomiting  1  7/85 (8.24%) 
General disorders   
Pyrexia  1  8/85 (9.41%) 
Infections and infestations   
Body tinea  1  5/85 (5.88%) 
Bronchitis  1  5/85 (5.88%) 
Nasopharyngitis  1  5/85 (5.88%) 
Respiratory tract infection  1  6/85 (7.06%) 
Rhinitis  1  8/85 (9.41%) 
Tinea capitis  1  7/85 (8.24%) 
Upper respiratory tract infection  1  33/85 (38.82%) 
Viral upper respiratory tract infection  1  9/85 (10.59%) 
Nervous system disorders   
Headache  1  14/85 (16.47%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  28/85 (32.94%) 
Skin and subcutaneous tissue disorders   
Rash  1  20/85 (23.53%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00905489     History of Changes
Other Study ID Numbers: 1100.1518
2008-005855-61 ( EudraCT Number: EudraCT )
First Submitted: May 6, 2009
First Posted: May 20, 2009
Results First Submitted: September 23, 2013
Results First Posted: May 7, 2014
Last Update Posted: January 7, 2016