Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00075270
First received: January 7, 2004
Last updated: February 13, 2014
Last verified: December 2013
Results First Received: March 14, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Neoplasms, Breast
Interventions: Drug: Paclitaxel
Drug: GW572016 (Lapatinib)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 580 participants were enrolled and randomized to treatment; however one participant withdrew from the study before taking any medication. Thus, only 579 participants were included in the Intent-to-Treat Population (comprised of all randomized participants who had received at least one dose of randomized therapy [lapatinib or placebo]).

Reporting Groups
  Description
Lapatinib With Paclitaxel Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
Placebo With Paclitaxel Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.

Participant Flow:   Overall Study
    Lapatinib With Paclitaxel     Placebo With Paclitaxel  
STARTED     291     288  
Missing     26 [1]   13 [1]
COMPLETED     5     4  
NOT COMPLETED     286     284  
Withdrawal by Subject                 28                 21  
Lost to Follow-up                 25                 28  
Protocol Violation                 0                 2  
Death                 198                 215  
Other/Unknown                 9                 5  
Missing                 26                 13  
[1] These participants have no completion status information recorded on the case report forms.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Lapatinib With Paclitaxel Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
Placebo With Paclitaxel Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
Total Total of all reporting groups

Baseline Measures
    Lapatinib With Paclitaxel     Placebo With Paclitaxel     Total  
Number of Participants  
[units: participants]
  291     288     579  
Age  
[units: Years]
Mean ± Standard Deviation
  51.3  ± 10.45     52.4  ± 10.98     51.8  ± 10.72  
Gender  
[units: Participants]
     
Female     291     288     579  
Male     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
     
White     190     182     372  
Black     10     10     20  
Asian     30     35     65  
American Hispanic     54     53     107  
Unknown     7     8     15  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Progression as Evaluated by the Investigator   [ Time Frame: Randomization until the date of disease progression or death (average of 26 weeks) ]

2.  Primary:   Time to Progression as Evaluated by the Independent Review Committee (IRC)   [ Time Frame: Randomization until the date of disease progression or death (average of 26 weeks) ]

3.  Secondary:   Number of Participants With Tumor Response as Evaluated by the Investigator   [ Time Frame: Randomization until the date of disease progression or death (average of 26 weeks) ]

4.  Secondary:   Number of Participants With Tumor Response as Evaluated by the Independent Review Committee   [ Time Frame: Randomization until the date of disease progression or death (average of 26 weeks) ]

5.  Secondary:   Percentage of Participants With Clinical Benefit (CB) as Assessed by the Investigator   [ Time Frame: Randomization until the date of disease progression or death (average of 26 weeks) ]

6.  Secondary:   Number of Participants With a Response of CR or PR by the Indicated Study Week   [ Time Frame: Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, and 72 ]

7.  Secondary:   Duration of Response (DOR)   [ Time Frame: From the time of the first documented complete or partial response until the first documented evidence of progression or death (average of 26 weeks) ]

8.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Randomization until the date of disease progression or death (average of 26 weeks) ]

9.  Secondary:   Number of Participants Who Progressed or Died at or Prior to 6 Months, as a Measure of Six Months Progression-free Survival (PFS)   [ Time Frame: Randomization until the date of disease progression or death (average of 26 weeks) ]

10.  Secondary:   Overall Survival   [ Time Frame: Randomization until the date of death due to any cause (average of 24 months) ]

11.  Secondary:   Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Questionnaire Scores   [ Time Frame: Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal ]

12.  Secondary:   Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores   [ Time Frame: Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal ]

13.  Secondary:   Change From Baseline in Trial Outcome Index (TOI) Questionnaire Scores   [ Time Frame: Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal ]

14.  Secondary:   Number of Participants With the Indicated ErbB2 Status at Baseline   [ Time Frame: Baseline ]

15.  Secondary:   ErbB2 Ratio   [ Time Frame: Baseline ]

16.  Secondary:   Number of Participants With the Indicated Immunohistochemistry (IHC) Results at Screening   [ Time Frame: Screening (Day -1) ]

17.  Secondary:   Number of Participants With the Indicated ErbB2 Fluorescence in Situ Hybridization (FISH) Results   [ Time Frame: Baseline ]

18.  Secondary:   Serum ErbB1 Concentration   [ Time Frame: Screening (Day-1) and Withdrawal (up to Study Week 129) ]

19.  Secondary:   Serum ErbB2 Concentration   [ Time Frame: Screening (Day-1) and Withdrawal (up to Study Week 129) ]

20.  Secondary:   Number of Participants With the Indicated Adverse Events (AEs) With a Maximum Toxicity Grade of 3 or 4   [ Time Frame: Baseline (Day 1) until 30 days after the last dose of randomized therapy (average of 26 weeks) ]


  Serious Adverse Events
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Time Frame Serious adverse events (SAEs) and adverse events were collected from the first dose of randomized therapy until 30 days after the last dose of randomized therapy (average of 26 weeks).
Additional Description SAEs and AEs were collected in the Safety Population, comprised of all randomized participants who received at least one dose of investigational product (based on the actual treatment received if this differed from that to which the participant was randomized). Two participants randomized to the placebo group actually received lapatinib.

Reporting Groups
  Description
Lapatinib With Paclitaxel Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
Placebo With Paclitaxel Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.

Serious Adverse Events
    Lapatinib With Paclitaxel     Placebo With Paclitaxel  
Total, serious adverse events      
# participants affected / at risk     103/293 (35.15%)     63/286 (22.03%)  
Blood and lymphatic system disorders      
Neutropenia † 1    
# participants affected / at risk     22/293 (7.51%)     14/286 (4.90%)  
Febrile neutropenia † 1    
# participants affected / at risk     10/293 (3.41%)     3/286 (1.05%)  
Disseminated intravascular coagulation † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Leukopenia † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Thrombocythemia † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Cardiac disorders      
Left ventricular dysfunction † 1    
# participants affected / at risk     2/293 (0.68%)     1/286 (0.35%)  
Atrial fibrillation † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Cardiac arrest † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Cardiac failure † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Myocardial infarction † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Ventricular arrhythmia † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Eye disorders      
Retinal detachment † 1    
# participants affected / at risk     1/293 (0.34%)     1/286 (0.35%)  
Ulcerative keratitis † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Pterygium † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Gastrointestinal disorders      
Diarrhea † 1    
# participants affected / at risk     24/293 (8.19%)     2/286 (0.70%)  
Vomiting † 1    
# participants affected / at risk     4/293 (1.37%)     4/286 (1.40%)  
Abdominal pain † 1    
# participants affected / at risk     2/293 (0.68%)     0/286 (0.00%)  
Nausea † 1    
# participants affected / at risk     1/293 (0.34%)     1/286 (0.35%)  
Ascites † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Constipation † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Gastrointestinal toxicity † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Ileus † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Intestinal ischemia † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Esophagitis † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Rectal hemorrhage † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Stomatitis † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
General disorders      
Pyrexia † 1    
# participants affected / at risk     7/293 (2.39%)     2/286 (0.70%)  
Mucosal inflammation † 1    
# participants affected / at risk     6/293 (2.05%)     1/286 (0.35%)  
Chest pain † 1    
# participants affected / at risk     2/293 (0.68%)     2/286 (0.70%)  
Asthenia † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Death † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Edema peripheral † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Performance status decreased † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Hepatobiliary disorders      
Cholecystitis † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Cholecystitis chronic † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Cholelithiasis † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Hepatotoxicity † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Jaundice cholestatic † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Immune system disorders      
Hypersensitivity † 1    
# participants affected / at risk     2/293 (0.68%)     1/286 (0.35%)  
Anaphylactic reaction † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Infections and infestations      
Pneumonia † 1    
# participants affected / at risk     3/293 (1.02%)     2/286 (0.70%)  
Device related infection † 1    
# participants affected / at risk     2/293 (0.68%)     1/286 (0.35%)  
Sepsis † 1    
# participants affected / at risk     2/293 (0.68%)     1/286 (0.35%)  
Septic shock † 1    
# participants affected / at risk     2/293 (0.68%)     0/286 (0.00%)  
Staphylococcal infection † 1    
# participants affected / at risk     1/293 (0.34%)     1/286 (0.35%)  
Urinary tract infection † 1    
# participants affected / at risk     2/293 (0.68%)     0/286 (0.00%)  
Acarodermatitis † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Breast abscess † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Bronchopneumonia † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Catheter site infection † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Cellulitis † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Enterocolitis infectious † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Gallbladder abscess † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Lower respiratory tract infection † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Lung infection † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Lymphangitis † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Oral candidiasis † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Pneumonia primary atypical † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Pyelonephritis † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Skin infection † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Urosepsis † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Injury, poisoning and procedural complications      
Ankle fracture † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Femur fracture † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Foot fracture † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Poisoning † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Investigations      
Ejection fraction decreased † 1    
# participants affected / at risk     5/293 (1.71%)     5/286 (1.75%)  
Hemoglobin decreased † 1    
# participants affected / at risk     1/293 (0.34%)     1/286 (0.35%)  
Alanine aminotransferase increased † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Blood creatinine increased † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Blood uric acid increased † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Body temperature increased † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Neutrophil count decreased † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Metabolism and nutrition disorders      
Hypercalcemia † 1    
# participants affected / at risk     4/293 (1.37%)     3/286 (1.05%)  
Dehydration † 1    
# participants affected / at risk     4/293 (1.37%)     0/286 (0.00%)  
Hypokalemia † 1    
# participants affected / at risk     2/293 (0.68%)     0/286 (0.00%)  
Fluid overload † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Hyperglycemia † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Hyperkalemia † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Hypernatremia † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Hyperuricemia † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Hypocalcemia † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Hypoglycemia † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Hypomagnesemia † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Hyponatremia † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Hypovolemia † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Tetany † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Musculoskeletal and connective tissue disorders      
Pain in extremity † 1    
# participants affected / at risk     3/293 (1.02%)     0/286 (0.00%)  
Arthralgia † 1    
# participants affected / at risk     2/293 (0.68%)     0/286 (0.00%)  
Pathological fracture † 1    
# participants affected / at risk     1/293 (0.34%)     1/286 (0.35%)  
Back pain † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Intervertebral disc disorder † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Joint effusion † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Muscular weakness † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Myalgia † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Breast cancer † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Metastases to central nervous system † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Tumor hemorrhage † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Nervous system disorders      
Convulsion † 1    
# participants affected / at risk     1/293 (0.34%)     1/286 (0.35%)  
Cerebral infarction † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Cerebrovascular disorder † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Headache † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Hemiplegia † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Lumber radiculopathy † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Mental impairment † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Neuralgia † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Peripheral motor neuropathy † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Peripheral sensory neuropathy † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Somnolence † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Syncope † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Psychiatric disorders      
Anxiety † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Confusional state † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Mental status changes † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Renal and urinary disorders      
Renal colic † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Renal failure acute † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Urinary retention † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Respiratory, thoracic and mediastinal disorders      
Dyspnea † 1    
# participants affected / at risk     3/293 (1.02%)     3/286 (1.05%)  
Pulmonary embolism † 1    
# participants affected / at risk     2/293 (0.68%)     0/286 (0.00%)  
Cough † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Epistaxis † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Hemothorax † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Hypoxia † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Pleural effusion † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Pneumonitis † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Pulmonary hemorrhage † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Pulmonary edema † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Wheezing † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Skin and subcutaneous tissue disorders      
Rash † 1    
# participants affected / at risk     4/293 (1.37%)     0/286 (0.00%)  
Erythema multiforme † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Intertrigo † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Rash erythematous † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Rash generalized † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Vascular disorders      
Hypotension † 1    
# participants affected / at risk     3/293 (1.02%)     0/286 (0.00%)  
Thrombosis † 1    
# participants affected / at risk     1/293 (0.34%)     2/286 (0.70%)  
Deep vein thrombosis † 1    
# participants affected / at risk     2/293 (0.68%)     0/286 (0.00%)  
Hypertension † 1    
# participants affected / at risk     0/293 (0.00%)     2/286 (0.70%)  
Embolism † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Hemorrhage † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Hypertensive crisis † 1    
# participants affected / at risk     1/293 (0.34%)     0/286 (0.00%)  
Phlebitis † 1    
# participants affected / at risk     0/293 (0.00%)     1/286 (0.35%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA




  Other Adverse Events


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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:
Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00075270     History of Changes
Obsolete Identifiers: NCT00085046
Other Study ID Numbers: EGF30001
Study First Received: January 7, 2004
Results First Received: March 14, 2013
Last Updated: February 13, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration