Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Compliance to Synagis (Palivizumab) Under Daily Pediatrician´s Conditions in Premature Infants 33 - 35 wGA

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: NCT01077271
Recruitment Status : Completed
First Posted : March 1, 2010
Results First Posted : August 21, 2012
Last Update Posted : August 21, 2012
Sponsor:
Collaborator:
Assign Data Management and Biostatistics GmbH
Information provided by (Responsible Party):
Abbott

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Premature Infants
Enrollment 124
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Premature Infants 33 - 35 wGA Prophylaxed With Palivizumab
Hide Arm/Group Description Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with palivizumab
Period Title: Overall Study
Started 124
Participants Treated With Palivizumab 120
Number of Participants Analyzed 120
Completed 102
Not Completed 22
Reason Not Completed
Parental desire             8
Screen failure, did not take palivizumab             4
Noncompliance             2
Quota used up (insurance reimb issue)             2
Changed doctors             2
Parents thought too many injections             2
End of RSV season nearly reached             1
Mother unconvinced of the necessity             1
Arm/Group Title RSV Season 1 RSV Season 2 RSV Season 3 No Matching RSV Season Total
Hide Arm/Group Description Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009) Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010) Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011) Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3 Total of all reporting groups
Overall Number of Baseline Participants 39 45 32 4 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 39 participants 45 participants 32 participants 4 participants 120 participants
Less than 1 month 1 1 2 1 5
1 month 10 15 7 0 32
Greater than 1 and less than or equal to 2 months 19 12 14 3 48
3 months 4 6 4 0 14
4 to 4.5 months 1 1 2 0 4
5 months 0 4 1 0 5
6 months 1 4 0 0 5
7 months 0 0 1 0 1
8 months 0 2 0 0 2
9 months 0 0 1 0 1
10 months 2 0 0 0 2
Age not reported 1 0 0 0 1
[1]
Measure Description: The chronological age of participants at study entry.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 45 participants 32 participants 4 participants 120 participants
Female
13
  33.3%
21
  46.7%
13
  40.6%
3
  75.0%
50
  41.7%
Male
26
  66.7%
24
  53.3%
19
  59.4%
1
  25.0%
70
  58.3%
Gestational age   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 39 participants 45 participants 32 participants 4 participants 120 participants
23 weeks 0 1 0 0 1
28 weeks 0 0 1 0 1
31 weeks 0 0 1 0 1
33 weeks 24 18 14 1 57
34 weeks 9 18 12 3 42
35 weeks 6 8 4 0 18
[1]
Measure Description: The gestational age of participants at birth in week of gestation.
Body weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 39 participants 45 participants 32 participants 4 participants 120 participants
3.9  (1.4) 3.8  (1.5) 4.1  (1.6) 3.5  (1.1) 3.9  (1.5)
[1]
Measure Description: The body weight of participants at the first study visit.
1.Primary Outcome
Title Number of Injections Per Patient Per Season
Hide Description The average number of injections administered per participant within a respiratory syncytial virus season.
Time Frame One RSV season (5 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were administered palivizumab were included in the analysis.
Arm/Group Title RSV Season 1 RSV Season 2 RSV Season 3 No Matching RSV Season Total
Hide Arm/Group Description:
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
Overall Number of Participants Analyzed 39 45 32 4 120
Mean (Standard Deviation)
Unit of Measure: Injections administered
3.8  (1.3) 3.9  (1.1) 4.0  (1.4) 1.0  (0.0) 3.8  (1.3)
2.Primary Outcome
Title Body Site of Injections Per Administration
Hide Description The body site of injection administration for participants at each study visit.
Time Frame One RSV season (5 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes participants who were administered palivizumab and had data available for the study visits listed.
Arm/Group Title RSV Season 1 RSV Season 2 RSV Season 3 No Matching RSV Season Total
Hide Arm/Group Description:
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
Overall Number of Participants Analyzed 39 45 32 4 120
Measure Type: Number
Unit of Measure: participants
Visit 1: Thigh 38 44 29 4 115
Visit 2: Thigh 34 43 32 0 109
Visit 3: Thigh 31 42 23 0 96
Visit 3: Other location 0 0 1 0 1
Visit 4: Thigh 20 28 22 0 70
Visit 4: Other location 0 0 1 0 1
Visit 5: Thigh 15 13 15 0 43
Visit 5: Other location 0 0 1 0 1
Visit 6: Thigh 5 3 3 0 11
Visit 6: Other location 0 0 1 0 1
Visit 7: Thigh 2 3 0 0 5
3.Primary Outcome
Title Interval Between Administrations
Hide Description The average number of days that elapsed between palivizumab injections administered at the previous study visit.
Time Frame One RSV season (5 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes participants who were administered palivizumab and had data available for the study visits listed.
Arm/Group Title RSV Season 1 (S1) RSV Season 2 (S2) RSV Season 3 (S3) No Matching RSV Season (NS) Total
Hide Arm/Group Description:
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
Overall Number of Participants Analyzed 39 45 32 4 120
Mean (Standard Deviation)
Unit of Measure: Days
V2 (S1 n=33; S2 n=42; S3 n=29; NS n=0) 28.5  (9.1) 30.6  (9.2) 28.6  (9.2) NA [1]   (NA) 29.4  (9.1)
V3 (S1 n=32; S2 n=42; S3 n=24; NS n=0) 33.2  (12.4) 34.7  (12.1) 30.3  (4.8) NA [1]   (NA) 33.1  (10.9)
V4 (S1 n=20; S2 n=28; S3 n=23; NS n=0) 34.5  (9.4) 41.8  (48.2) 32.0  (5.5) NA [1]   (NA) 36.6  (30.8)
V5 (S1 n=15; S2 n=13; S3 n=16; NS n=0) 33.4  (13.9) 32.5  (12.9) 28.4  (5.5) NA [1]   (NA) 31.3  (11.2)
V6 (S1 n=6; S2 n=3; S3 n=4; NS n=0) 24.8  (10.3) 30.0  (1.7) 29.5  (1.7) NA [1]   (NA) 27.5  (7.2)
V7 (S1 n=2; S2 n=3; S3 n=0; NS n=0) 34.0  (0.0) 30.0  (1.7) NA [1]   (NA) NA [1]   (NA) 31.6  (2.5)
[1]
No data reported for this subgroup at this time point.
4.Primary Outcome
Title Dosage Per Administration
Hide Description The median dose and range of palivizumab (milligrams) that was administered at each study visit.
Time Frame One RSV season (5 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes participants who were administered palivizumab and had data available for the study visits listed.
Arm/Group Title RSV Season 1 (S1) RSV Season 2 (S2) RSV Season 3 (S3) No Matching RSV Season (NS) Total
Hide Arm/Group Description:
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
Overall Number of Participants Analyzed 39 45 32 4 120
Median (Full Range)
Unit of Measure: milligrams
V1 (S1 n=36; S2 n=44; S3 n=26; NS n=4)
60.0
(40.0 to 7500.0)
50.0
(24.0 to 150.0)
73.5
(30.0 to 125.0)
52.5
(50.0 to 100.0)
60.0
(24.0 to 7500.0)
V2 (S1 n=32; S2 n=43; S3 n=27; NS n=0)
77.5
(50.0 to 5000.0)
70.0
(50.0 to 150.0)
84.0
(43.0 to 130.0)
NA [1] 
(NA to NA)
79.5
(43.0 to 5000.0)
V3 (S1 n=29; S2 n=42; S3 n=21; NS n=0)
85.0
(60.0 to 10000.0)
80.0
(45.0 to 150.0)
96.0
(58.0 to 140.0)
NA [1] 
(NA to NA)
85.5
(45.0 to 10000.0)
V4 (S1 n=20; S2 n=28; S3 n=20; NS n=0)
99.0
(73.0 to 8000.0)
97.5
(54.0 to 1600.0)
100.0
(65.0 to 150.0)
NA [1] 
(NA to NA)
100.0
(54.0 to 8000.0)
V5 (S1 n=15; S2 n=13; S3 n=13; NS n=0)
100.0
(80.0 to 111.0)
100.0
(80.0 to 150.0)
100.0
(78.0 to 150.0)
NA [1] 
(NA to NA)
100.0
(78.0 to 150.0)
V6 (S1 n=5; S2 n=3; S3 n=2; NS n=0)
100.0
(90.0 to 123.0)
100.0
(100.0 to 130.0)
101.0
(95.0 to 107.0)
NA [1] 
(NA to NA)
100.0
(90.0 to 130.0)
V7 (S1 n=2; S2 n=3; S3 n=0; NS n=0)
100.0
(100.0 to 100.0)
100.0
(100.0 to 100.0)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
100.0
(100.0 to 100.0)
[1]
No data reported for this subgroup at this time point.
5.Secondary Outcome
Title Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)
Hide Description The clinician who administered the palivizumab injection was asked to rate pain during injection using a visual analog scale (VAS) and the Modified Behavior Pain Scale (MBPS) as published by Carbajal et al., 2008. The VAS ranged from 0 (no pain) to 100 (maximum pain). The Modified Behavioral Pain Scale ranged from 0 (no pain) to 10 (maximum pain) through the evaluation of 3 items: Facial expressions, cry, and movements. If more than one injection was given at a visit, then the first injection was rated.
Time Frame One RSV season (5 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included participants who were administered palivizumab and had data available for the study visits listed.
Arm/Group Title RSV Season 1 (S1) RSV Season 2 (S2) RSV Season 3 (S3) No Matching RSV Season (NS) Total
Hide Arm/Group Description:
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
Overall Number of Participants Analyzed 39 45 32 4 120
Mean (Standard Deviation)
Unit of Measure: units on a scale
V1 VAS (S1 n=37; S2 n=43; S3 n=22; NS n=4) 50.2  (22.3) 64.1  (19.5) 53.5  (25.7) 62.5  (9.6) 57.0  (22.3)
V1 MBPS (S1 n=37; S2 n=43; S3 n=29; NS n=4) 7.2  (1.7) 7.5  (1.5) 6.9  (1.8) 7.8  (1.5) 7.2  (1.7)
V2 VAS (S1 n=33; S2 n=42; S3 n=25; NS n=0) 55.3  (23.4) 65.6  (18.2) 57.2  (27.3) NA [1]   (NA) 60.1  (22.7)
V2 MBPS (S1 n=34; S2 n=42; S3 n=31; NS n=0) 7.2  (1.6) 7.9  (1.5) 7.3  (1.9) NA [1]   (NA) 7.5  (1.6)
V3 VAS (S1 n=31; S2 n=41; S3 n=20; NS n=0) 55.9  (23.6) 67.8  (16.4) 60.0  (26.6) NA [1]   (NA) 62.1  (21.9)
V3 MBPS (S1 n=31; S2 n=41; S3 n=24; NS n=0) 7.3  (1.5) 7.9  (1.3) 7.6  (1.8) NA [1]   (NA) 7.7  (1.5)
V4 VAS (S1 n=20; S2 n=28; S3 n=19; NS n=0) 60.3  (24.5) 66.3  (17.1) 62.7  (23.5) NA [1]   (NA) 63.5  (21.2)
V4 MBPS (S1 n=20; S2 n=28; S3 n=22; NS n=0) 8.2  (1.2) 7.7  (1.4) 7.4  (1.3) NA [1]   (NA) 7.7  (1.3)
V5 VAS (S1 n=15; S2 n=13; S3 n=14; NS n=0) 55.1  (28.1) 65.8  (13.2) 64.4  (27.4) NA [1]   (NA) 61.5  (24.1)
V5 MBPS (S1 n=15; S2 n=13; S3 n=16; NS n=0) 6.9  (2.1) 7.2  (1.4) 8.2  (1.5) NA [1]   (NA) 7.5  (1.8)
V6 VAS (S1 n=5; S2 n=3; S3 n=4; NS n=0) 51.2  (31.2) 78.3  (2.9) 72.0  (34.3) NA [1]   (NA) 64.9  (28.8)
V6 MBPS (S1 n=5; S2 n=3; S3 n=4; NS n=0) 7.4  (2.2) 7.3  (0.6) 8.8  (1.9) NA [1]   (NA) 7.8  (1.8)
V7 VAS (S1 n=2; S2 n=3; S3 n=0; NS n=0) 30.0  (0.0) 73.3  (11.5) NA [1]   (NA) NA [1]   (NA) 56.0  (25.1)
V7 MBPS (S1 n=2; S2 n=3; S3 n=0; NS n=0) 4.0  (1.4) 6.7  (1.2) NA [1]   (NA) NA [1]   (NA) 5.6  (1.8)
[1]
No data reported for this subgroup at this time point.
6.Secondary Outcome
Title Parents Knowledge of Burden of RSV Disease Via Interview by Physician
Hide Description An informational brochure was given to parents of participants. Parents were interviewed by the treating physician at the first study visit (V1) and last study visit (LSV) (or early termination visit [ET]) for those participants discontinuing from the study). Parental knowledge of the burden of respiratory syncytial virus (RSV) disease was assessed using a questionnaire. Parents were considered to have "good RSV awareness" if all questions were answered and at least 3 of the 4 questions regarding the burden of RSV disease were answered correctly.
Time Frame One RSV season (5 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included parents of participants who were administered and had data available for the study visits listed.
Arm/Group Title RSV Season 1 (S1) RSV Season 2 (S2) RSV Season 3 (S3) No Matching RSV Season (NS) Total
Hide Arm/Group Description:
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
Overall Number of Participants Analyzed 39 45 32 4 120
Measure Type: Number
Unit of Measure: Parents of participants
Good RSV Awareness V1 (S1=39;S2=42;S3=32;NS=4) 39 36 31 4 110
Good RSV Awareness LSV (S1=28;S2=32;S3=29;NS=4) 28 32 29 4 93
Good RSV Awareness ET (S1=7;S2=8;S3=3;NS=0) 7 7 3 0 17
7.Secondary Outcome
Title Effectiveness of Palivizumab at the End of the Observation Period is Checked by the Physician by Ranking in a Visible Analog Scale
Hide Description The therapeutic effect of palivizumab was assessed by the treating physician using a visual analog scale from 0 to 10, where 0 indicated that palivizumab did not match expectations at all and 10 indicated that palivizumab met all expectations. The physician rated palivizumab treatment for each participant at the last study visit (LSV) or, in the case of participants withdrawing from the study, at the early termination (ET) visit.
Time Frame One RSV season (5 months), end of study
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included participants who were administered palivizumab and had data available for the study visits listed. A total of 100 participants were rated at the last study visit; 2 did not have ratings. A total of 18 participants who discontinued from the study were rated at the early termination visit.
Arm/Group Title RSV Season 1 (S1) RSV Season 2 (S2) RSV Season 3 (S3) No Matching RSV Season (NS) Total
Hide Arm/Group Description:
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
Overall Number of Participants Analyzed 39 45 32 4 120
Mean (Standard Deviation)
Unit of Measure: units on a scale
Rating at LSV (S1 n=30;S2 n=36;S3 n=27;NS n=4) 9.9  (0.4) 9.8  (0.6) 9.9  (0.5) 10.0  (0.0) 9.9  (0.5)
Rating at ET visit (S1 n=7;S2 n=8;S3 n=3;NS n=0) 10.0  (0.0) 9.5  (0.9) 10.0  (0.0) NA [1]   (NA) 9.8  (0.6)
[1]
No participants in this subgroup were rated at an early termination visit.
Time Frame Adverse events were reported from the time informed consent was given until 90 days after the last dose of palivizumab. The average time from first to last study visit was approximately 125 days, with an average therapy duration of approximately 93 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Premature Infants 33 - 35 wGA Prophylaxed With Palivizumab
Hide Arm/Group Description Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with palivizumab
All-Cause Mortality
Premature Infants 33 - 35 wGA Prophylaxed With Palivizumab
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Premature Infants 33 - 35 wGA Prophylaxed With Palivizumab
Affected / at Risk (%)
Total   5/120 (4.17%) 
Gastrointestinal disorders   
Inguinal hernia † 1  1/120 (0.83%) 
Infections and infestations   
Pneumonia † 1  2/120 (1.67%) 
Bronchitis † 1  1/120 (0.83%) 
Surgical and medical procedures   
Hospitalisation † 1  1/120 (0.83%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Premature Infants 33 - 35 wGA Prophylaxed With Palivizumab
Affected / at Risk (%)
Total   22/120 (18.33%) 
Blood and lymphatic system disorders   
Iron deficiency anaemia † 1  2/120 (1.67%) 
Infections and infestations   
Bronchitis † 1  4/120 (3.33%) 
Rhinitis † 1  3/120 (2.50%) 
Varicella † 1  3/120 (2.50%) 
Bronchitis viral † 1  2/120 (1.67%) 
Nasopharyngitis † 1  2/120 (1.67%) 
Respiratory tract infection † 1  2/120 (1.67%) 
Upper respiratory tract infection † 1  2/120 (1.67%) 
Skin and subcutaneous tissue disorders   
Dermatitis atopic † 1  2/120 (1.67%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
[Not Specified]
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.
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: Abbott
Phone: 1-800-633-9110
Layout table for additonal information
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01077271    
Other Study ID Numbers: P11-040
First Submitted: February 25, 2010
First Posted: March 1, 2010
Results First Submitted: May 17, 2012
Results First Posted: August 21, 2012
Last Update Posted: August 21, 2012