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Trial record 21 of 1164 for:    MYCOPHENOLIC ACID

Comparative Bioavailability of Myfenax® and CellCept® in Kidney Transplant Patients

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: NCT00991510
Recruitment Status : Terminated (Slow recruitment and lack of time to product launch)
First Posted : October 8, 2009
Results First Posted : July 30, 2013
Last Update Posted : November 8, 2018
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Stable Renal Transplant Recipients
Interventions Drug: mycophenolate mofetil (Myfenax)
Drug: mycophenolate mofetil (Cellcept)
Enrollment 43
Recruitment Details  
Pre-assignment Details A total of 100 subjects were planned. A total of 47 subjects were screened in the study. Four subjects were not randomised, i.e., two subjects withdrew consent, one subject had a protocol violation, and one subject was a screening failure (did not meet eligibility criteria).
Arm/Group Title Reference/Test/Test Test/Reference/Reference
Hide Arm/Group Description

The reference product was CellCept® and test product was Myfenax®. In period I, participants received CellCept on Days 1-14. In period II, participants crossed-over to receive Myfenax on Days 15-28. In period III, participants received Myfenax until the end of the study (Days 29-112).

Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.

The test product was Myfenax® and the reference product was CellCept®. In period I, participants received Myfenax on Days 1-14. In period II, participants crossed-over to receive CellCept on Days 15-28. In period III, participants received CellCept until the end of the study (Days 29-112).

Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.

Period Title: Period I (Days 1-14)
Started 22 21
Completed 21 21
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Period Title: Period II (Days 15-28)
Started 21 21
Completed 21 21
Not Completed 0 0
Period Title: Period III (Days 29-112)
Started 21 21
Completed 20 20
Not Completed 1 1
Reason Not Completed
Adverse Event             1             1
Arm/Group Title Reference/Test/Test Test/Reference/Reference Total
Hide Arm/Group Description

The reference product was CellCept® and test product was Myfenax®. In period I, participants received CellCept on Days 1-14. In period II, participants crossed-over to receive Myfenax on Days 15-28. In period III, participants received Myfenax until the end of the study (Days 29-112).

Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.

The test product was Myfenax® and the reference product was CellCept®. In period I, participants received Myfenax on Days 1-14. In period II, participants crossed-over to receive CellCept on Days 15-28. In period III, participants received CellCept until the end of the study (Days 29-112).

Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.

Total of all reporting groups
Overall Number of Baseline Participants 22 21 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 21 participants 43 participants
49.7  (13.73) 51.7  (13.55) 50.7  (13.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 43 participants
Female
11
  50.0%
8
  38.1%
19
  44.2%
Male
11
  50.0%
13
  61.9%
24
  55.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 43 participants
Asian 1 0 1
Caucasian 21 21 42
Height  
Mean (Standard Deviation)
Unit of measure:  Meters
Number Analyzed 22 participants 21 participants 43 participants
1.711  (0.1061) 1.718  (0.0983) 1.714  (0.1012)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 22 participants 21 participants 43 participants
77.19  (14.856) 77.23  (15.661) 77.21  (15.072)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 22 participants 21 participants 43 participants
26.24  (3.756) 25.93  (3.422) 26.09  (3.557)
1.Primary Outcome
Title Area Under the Plasma Concentration-time Curve (AUC(0-6h)) of Mycophenolate Mofetil
Hide Description Area under the plasma concentration-time curve during a dosage interval at steady state (calculated using the trapezoidal rule, from t = 0 to t = 6 hours).
Time Frame Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.
Arm/Group Title CellCept Myfenax
Hide Arm/Group Description:
Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
Overall Number of Participants Analyzed 41 41
Mean (Standard Deviation)
Unit of Measure: hour* µg /ml
33.523  (15.1265) 31.100  (15.4198)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CellCept, Myfenax
Comments A total of 100 subjects were planned to be enrolled, allowing for 10% drop-out rate. Based on previous single dose studies, the intra-subject coefficients of variation were 14% and 50% for AUC and Cmax, respectively. Based on the literature similar intra subject coefficients of variation were observed in steady-state patients. With these expected CV(%) and an expected ratio of Cmax within 0.95 and 1.05, the study should have a power of at least 80 % to show bioequivalence with 80 subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence was accepted if the calculated 90 % CIs were within 0.80-1.25.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter adjusted least-squares mean ratio
Estimated Value 0.923
Confidence Interval (2-Sided) 90%
0.865 to 0.984
Estimation Comments [Not Specified]
2.Primary Outcome
Title Area Under the Plasma Concentration-time Curve (AUC(0-tau)) of Mycophenolate Mofetil
Hide Description For participants with a 0-12h profile: Area under the plasma concentration-time curve during a dosage interval at steady state (calculated using the trapezoidal rule, from t = 0 to t = 12 hours). For participants with a 0-6h profile: AUC(0-tau) was calculated based on AUC(0-6h) using the extrapolation formula according to Fleming.
Time Frame Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.
Arm/Group Title CellCept Myfenax
Hide Arm/Group Description:
Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
Overall Number of Participants Analyzed 41 41
Mean (Standard Deviation)
Unit of Measure: hour* µg /ml
49.846  (20.8278) 48.255  (21.2246)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CellCept, Myfenax
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence was accepted if the calculated 90 % CIs were within 0.80-1.25.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter adjusted least-squares mean ratio
Estimated Value 0.959
Confidence Interval (2-Sided) 90%
0.899 to 1.023
Estimation Comments [Not Specified]
3.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Mycophenolate Mofetil
Hide Description Cmax was directly obtained from measured values of plasma concentrations.
Time Frame Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.
Arm/Group Title CellCept Myfenax
Hide Arm/Group Description:
Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
Overall Number of Participants Analyzed 41 41
Mean (Standard Deviation)
Unit of Measure: µg /ml
16.189  (9.9448) 14.308  (8.3432)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CellCept, Myfenax
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence was accepted if the calculated 90 % CIs were within 0.80-1.25.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter adjusted least-squares mean ratio
Estimated Value 0.873
Confidence Interval (2-Sided) 90%
0.787 to 0.968
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Minimum Observed Plasma Concentration (Cmin) of Mycophenolate Mofetil
Hide Description Cmin was directly obtained from measured values of plasma concentrations.
Time Frame Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.
Arm/Group Title CellCept Myfenax
Hide Arm/Group Description:
Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
Overall Number of Participants Analyzed 41 41
Mean (Standard Deviation)
Unit of Measure: µg /ml
1.584  (0.7801) 1.567  (0.7387)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CellCept, Myfenax
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence was accepted if the calculated 90 % CIs were within 0.80-1.25.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter adjusted least-squares mean ratio
Estimated Value 0.985
Confidence Interval (2-Sided) 90%
0.877 to 1.106
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Plasma Concentrations of Mycophenolate Mofetil in Pre-Administration Samples (Cpd)
Hide Description Cpd was directly obtained from measured values of plasma concentrations.
Time Frame Day 14 and Day 28 (end of first two cross-over periods) before drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.
Arm/Group Title CellCept Myfenax
Hide Arm/Group Description:
Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
Overall Number of Participants Analyzed 41 41
Mean (Standard Deviation)
Unit of Measure: µg /ml
2.693  (1.7001) 3.001  (2.0863)
6.Secondary Outcome
Title Degree of Fluctuation of the Concentration Levels of Mycophenolate Mofetil Over One Dosing Interval (PTF)
Hide Description PTF was calculated as: (Cmax-Cmin)/(AUCt/t)*100
Time Frame Day 14 and Day 28 (end of first two cross-over periods) before drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.
Arm/Group Title CellCept Myfenax
Hide Arm/Group Description:
Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
Overall Number of Participants Analyzed 41 41
Mean (Standard Deviation)
Unit of Measure: percentage of AUC for a dosing interval
351.05  (161.195) 323.67  (156.018)
7.Secondary Outcome
Title Time Corresponding to Occurrence of Cmax (Tmax) of Mycophenolate Mofetil
Hide Description Tmax was directly obtained from measured values.
Time Frame Day 14 and Day 28 (end of first two cross-over periods) before drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.
Arm/Group Title CellCept Myfenax
Hide Arm/Group Description:
Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
Overall Number of Participants Analyzed 41 41
Mean (Standard Deviation)
Unit of Measure: hours
1.119  (0.7462) 1.344  (1.1439)
8.Secondary Outcome
Title Summary of Participants With Adverse Events
Hide Description

Summary of adverse events across three study time periods. The on-treatment time frame spanned the time during which study drug was administered. Relation to study drug was assessed by the investigator.

The Adverse Event count includes serious and non-serious AEs. A serious AE (SAE) was any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect or was an important medical event could have jeopardized the patient's safety or required medical or surgical intervention to prevent one of the outcomes listed above.

Severity was measured on a three-point scale: mild, moderate, severe.

Time Frame Day 1 up to Day 112
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. One participant discontinued the study prior to Period II so the Myfenax # participants analyzed is one less than the CellCept arm.
Arm/Group Title CellCept Myfenax Overall
Hide Arm/Group Description:
Participants experience while on CellCept during any of the three study periods. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
Participants experience while on Myfenax during any of the three study periods. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
Participant experience overall, i.e. all treatment experiences while on study are included
Overall Number of Participants Analyzed 43 42 43
Measure Type: Number
Unit of Measure: participants
Adverse Events 15 17 26
Related adverse events 3 7 9
Severe adverse events 0 0 0
Adverse events leading to discontinuation 2 1 3
Serious adverse events 1 1 1
Adverse events leading to death 0 0 0
Time Frame Day 1 up to Day 112
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CellCept Myfenax Overall
Hide Arm/Group Description Participants experience while on CellCept during any of the three study periods. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening. Participants experience while on Myfenax during any of the three study periods. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening. Participant experience overall, i.e. all treatment experiences while on study are included
All-Cause Mortality
CellCept Myfenax Overall
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CellCept Myfenax Overall
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/43 (2.33%)   1/42 (2.38%)   1/43 (2.33%) 
Cardiac disorders       
Atrial fibrillation  1  1/43 (2.33%)  1/42 (2.38%)  1/43 (2.33%) 
Cardiac failure  1  1/43 (2.33%)  0/42 (0.00%)  1/43 (2.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CellCept Myfenax Overall
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/43 (34.88%)   16/42 (38.10%)   26/43 (60.47%) 
Blood and lymphatic system disorders       
Lymphadenopathy  1  0/43 (0.00%)  1/42 (2.38%)  1/43 (2.33%) 
Ear and labyrinth disorders       
Vertigo  1  0/43 (0.00%)  1/42 (2.38%)  1/43 (2.33%) 
Eye disorders       
Conjunctivitis allergic  1  1/43 (2.33%)  0/42 (0.00%)  1/43 (2.33%) 
Gastrointestinal disorders       
Diarrhoea  1  2/43 (4.65%)  5/42 (11.90%)  6/43 (13.95%) 
Abdominal pain  1  1/43 (2.33%)  2/42 (4.76%)  3/43 (6.98%) 
Nausea  1  0/43 (0.00%)  2/42 (4.76%)  2/43 (4.65%) 
Abdominal distension  1  0/43 (0.00%)  1/42 (2.38%)  1/43 (2.33%) 
Dry mouth  1  0/43 (0.00%)  1/42 (2.38%)  1/43 (2.33%) 
Periodontitis  1  1/43 (2.33%)  0/42 (0.00%)  1/43 (2.33%) 
Rectal discharge  1  1/43 (2.33%)  0/42 (0.00%)  1/43 (2.33%) 
Vomiting  1  0/43 (0.00%)  1/42 (2.38%)  1/43 (2.33%) 
General disorders       
Oedema peripheral  1  2/43 (4.65%)  0/42 (0.00%)  2/43 (4.65%) 
Application site erythema  1  1/43 (2.33%)  0/42 (0.00%)  1/43 (2.33%) 
Chills  1  0/43 (0.00%)  1/42 (2.38%)  1/43 (2.33%) 
Infections and infestations       
Herpes simplex  1  2/43 (4.65%)  0/42 (0.00%)  2/43 (4.65%) 
Nasopharyngitis  1  2/43 (4.65%)  0/42 (0.00%)  2/43 (4.65%) 
Upper respiratory tract infection  1  0/43 (0.00%)  2/42 (4.76%)  2/43 (4.65%) 
Bronchitis  1  1/43 (2.33%)  0/42 (0.00%)  1/43 (2.33%) 
Herpes zoster  1  0/43 (0.00%)  1/42 (2.38%)  1/43 (2.33%) 
Lower respiratory tract infection  1  0/43 (0.00%)  1/42 (2.38%)  1/43 (2.33%) 
Rhinitis  1  1/43 (2.33%)  0/42 (0.00%)  1/43 (2.33%) 
Urinary tract infection  1  0/43 (0.00%)  1/42 (2.38%)  1/43 (2.33%) 
Injury, poisoning and procedural complications       
Arthropod bite  1  0/43 (0.00%)  1/42 (2.38%)  1/43 (2.33%) 
Joint injury  1  1/43 (2.33%)  0/42 (0.00%)  1/43 (2.33%) 
Ulna fracture  1  1/43 (2.33%)  0/42 (0.00%)  1/43 (2.33%) 
Investigations       
Blood pressure increased  1  2/43 (4.65%)  0/42 (0.00%)  2/43 (4.65%) 
Blood triglycerides increased  1  1/43 (2.33%)  0/42 (0.00%)  1/43 (2.33%) 
Cardiac murmur  1  0/43 (0.00%)  1/42 (2.38%)  1/43 (2.33%) 
Metabolism and nutrition disorders       
Hyponatraemia  1  1/43 (2.33%)  0/42 (0.00%)  1/43 (2.33%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/43 (0.00%)  2/42 (4.76%)  2/43 (4.65%) 
Back pain  1  0/43 (0.00%)  1/42 (2.38%)  1/43 (2.33%) 
Intervertebral disc protrusion  1  1/43 (2.33%)  0/42 (0.00%)  1/43 (2.33%) 
Musculoskeletal stiffness  1  1/43 (2.33%)  0/42 (0.00%)  1/43 (2.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bowenoid papulosis  1  1/43 (2.33%)  0/42 (0.00%)  1/43 (2.33%) 
Nervous system disorders       
Headache  1  1/43 (2.33%)  3/42 (7.14%)  3/43 (6.98%) 
Tremor  1  0/43 (0.00%)  1/42 (2.38%)  1/43 (2.33%) 
Psychiatric disorders       
Depression  1  1/43 (2.33%)  0/42 (0.00%)  1/43 (2.33%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  2/43 (4.65%)  0/42 (0.00%)  2/43 (4.65%) 
Skin and subcutaneous tissue disorders       
Onychoclasis  1  1/43 (2.33%)  0/42 (0.00%)  1/43 (2.33%) 
Rash  1  0/43 (0.00%)  1/42 (2.38%)  1/43 (2.33%) 
Vascular disorders       
Hypertension  1  0/43 (0.00%)  1/42 (2.38%)  1/43 (2.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
The study was designed to have a power of at least 80 % to show bioequivalence with 80 subjects. Only 43 subjects were included.
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.
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor’s review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor’s designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Results Point of Contact
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 215-591-3000
Publications of Results:
Sunder-Plassmann G et al.: Results of a Comparative Bioavailability Study of Myfenax (Teva) and CellCept (Roche) in Stable Kidney Transplant Recipients. American Transplant Congress 2011. Abstract Number: 250308
Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00991510     History of Changes
Other Study ID Numbers: 116B8
2009-010562-31 ( EudraCT Number )
First Submitted: August 29, 2009
First Posted: October 8, 2009
Results First Submitted: May 13, 2013
Results First Posted: July 30, 2013
Last Update Posted: November 8, 2018