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A Phase 1b Study of IV PRM151 in Patients With Idiopathic Pulmonary Fibrosis (IPF) (PRM151F-12GL)

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: NCT01254409
Recruitment Status : Completed
First Posted : December 6, 2010
Results First Posted : November 2, 2014
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Promedior, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Idiopathic Pulmonary Fibrosis
Interventions Biological: PRM-151
Other: Placebo
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo PRM-151 1 mg/kg PRM-151 5 mg/kg PRM-151 10 mg/kg
Hide Arm/Group Description 0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15 PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15 PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15 PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
Period Title: Overall Study
Started 6 6 5 4
Completed 6 5 5 4
Not Completed 0 1 0 0
Reason Not Completed
Adverse Event             0             1             0             0
Arm/Group Title Placebo PRM-151 1 mg/kg PRM-151 5 mg/kg PRM-151 10 mg/kg Total
Hide Arm/Group Description 0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15 PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15 PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15 PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15 Total of all reporting groups
Overall Number of Baseline Participants 6 6 5 4 21
Hide Baseline Analysis Population Description
All subjects enrolled in study
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 5 participants 4 participants 21 participants
65.5  (12.88) 63.7  (8.45) 70.6  (8.26) 66.5  (5.69) 66.4  (9.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 5 participants 4 participants 21 participants
Female
2
  33.3%
1
  16.7%
1
  20.0%
0
   0.0%
4
  19.0%
Male
4
  66.7%
5
  83.3%
4
  80.0%
4
 100.0%
17
  81.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 5 participants 4 participants 21 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.8%
White
5
  83.3%
6
 100.0%
5
 100.0%
4
 100.0%
20
  95.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 5 participants 4 participants 21 participants
United States 2 1 2 4 9
Netherlands 4 5 3 0 12
FVC   [1] 
Mean (Standard Deviation)
Unit of measure:  Liters
Number Analyzed 6 participants 6 participants 5 participants 4 participants 21 participants
2.15  (0.64) 2.96  (0.85) 2.78  (0.73) 2.97  (0.71) 2.67  (0.76)
[1]
Measure Description: Forced Vital Capacity: volume of air that can forcibly be blown out after full inspiration, measured in liters
FVC % Predicted   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 6 participants 6 participants 5 participants 4 participants 21 participants
63.2  (16.7) 82.4  (15.5) 80.0  (7.8) 72.8  (14.3) 74.1  (15.3)
[1]
Measure Description: The % of the FVC that would be predicted for a subject based on physical characteristics that influence the maximal inhalation: height, age, and gender.
FEV1 % Predicted   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 6 participants 6 participants 5 participants 4 participants 21 participants
68.8  (17.7) 85.8  (16.8) 87.0  (11.9) 73.0  (12.1) 78.5  (16.2)
[1]
Measure Description: Forced Expiratory Volume 1 second: the volume of air expired in the first second during maximal expiratory effort. FEV1% predicted is the FEV1% of the patient divided by the average FEV1% in the population for any person of similar age, sex and body composition
DLCO   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 6 participants 6 participants 5 participants 4 participants 21 participants
35.2  (8.4) 41.2  (10.5) 52.8  (9.8) 46.0  (7.2) 43.3  (10.9)
[1]
Measure Description: Diffusing capacity carbon monoxide is the carbon monoxide uptake from a single inspiration in a standard time (usually 10 seconds). DLCO% predicted is the % of the DLCO that would be predicted based on the subject's hemoglobin.
1.Primary Outcome
Title Safety and Tolerability
Hide Description Number of subjects with Dose Limiting Toxicities, Number of Treatment Emergent Serious Adverse Events and Adverse Events
Time Frame From first dose on Day 1 through Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one dose of study treatment
Arm/Group Title Placebo PRM-151 1 mg/kg PRM-151 5 mg/kg PRM-151 10 mg/kg
Hide Arm/Group Description:
0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
Overall Number of Participants Analyzed 6 6 5 4
Measure Type: Number
Unit of Measure: participants
Dose Limiting Toxicities 0 0 0 0
Serious Adverse Events 0 0 0 0
Adverse Events 6 6 5 4
2.Secondary Outcome
Title Cmax
Hide Description Maximum concentration
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received all doses of study treatment
Arm/Group Title PRM-151 1 mg/kg PRM-151 5 mg/kg PRM-151 10 mg/kg
Hide Arm/Group Description:
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
Overall Number of Participants Analyzed 5 5 4
Mean (Standard Deviation)
Unit of Measure: µg/mL
25.5  (7.9) 145  (41.9) 225  (43.7)
3.Secondary Outcome
Title Tmax
Hide Description Time of Maximum observed concentration
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PRM-151 1 mg/kg PRM-151 5 mg/kg PRM-151 10 mg/kg
Hide Arm/Group Description:
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
Overall Number of Participants Analyzed 5 5 4
Mean (Standard Deviation)
Unit of Measure: hours
5.35  (10.4) 1.30  (1.51) 0.69  (1.25)
4.Secondary Outcome
Title AUC48
Hide Description Area under the curve from 0 to 48 hrs post dose, with samples collected at 0.5, 0.75, 1, 1.5, 2, 3,4,6,8,12,16, 24 and 48 hours post Day 15 dose.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PRM-151 1 mg/kg PRM-151 5 mg/kg PRM-151 10 mg/kg
Hide Arm/Group Description:
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
Overall Number of Participants Analyzed 5 5 4
Mean (Standard Deviation)
Unit of Measure: µg*hr/mL
446  (118) 2190  (1140) 4710  (1180)
5.Secondary Outcome
Title Terminal Elimination Half Life
Hide Description [Not Specified]
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PRM-151 1 mg/kg PRM-151 5 mg/kg PRM-151 10 mg/kg
Hide Arm/Group Description:
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
Overall Number of Participants Analyzed 5 5 4
Mean (Full Range)
Unit of Measure: hour
21.7
(14.0 to 29.3)
43.6
(11.2 to 79.2)
71.6
(32.8 to 110.0)
6.Secondary Outcome
Title Total Body Clearance
Hide Description [Not Specified]
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PRM-151 1 mg/kg PRM-151 5 mg/kg PRM-151 10 mg/kg
Hide Arm/Group Description:
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
Overall Number of Participants Analyzed 5 5 4
Mean (Full Range)
Unit of Measure: ml/hr/kg
2.33
(1.17 to 3.48)
1.59
(0.780 to 2.65)
1.09
(0.749 to 1.42)
7.Secondary Outcome
Title Vss
Hide Description Volume of Distribution at Steady State
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PRM-151 1 mg/kg PRM-151 5 mg/kg PRM-151 10 mg/kg
Hide Arm/Group Description:
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
Overall Number of Participants Analyzed 5 5 4
Mean (Full Range)
Unit of Measure: mL/kg
53.9
(49.8 to 57.9)
73.9
(37.6 to 139.0)
72.0
(58.8 to 85.2)
8.Secondary Outcome
Title FVC (Forced Vital Capacity) Change From Baseline to Day 57
Hide Description [Not Specified]
Time Frame Change from Day 1 (Baseline) to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo PRM-151 1 mg/kg PRM-151 5 mg/kg PRM-151 10 mg/kg
Hide Arm/Group Description:
0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
Overall Number of Participants Analyzed 6 5 5 4
Mean (Standard Deviation)
Unit of Measure: liters
-0.063  (0.116) 0.058  (0.164) 0.060  (0.074) 0.078  (0.210)
9.Secondary Outcome
Title FVC (Forced Vital Capacity) % Predicted Change From Baseline
Hide Description [Not Specified]
Time Frame Day 1 (Baseline) and Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo PRM-151 1 mg/kg PRM-151 5 mg/kg PRM-151 10 mg/kg
Hide Arm/Group Description:
0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
Overall Number of Participants Analyzed 6 5 5 4
Mean (Standard Deviation)
Unit of Measure: absolute change in % predicted FVC
-1.5  (3.3) 2.4  (4.6) 2.8  (3.0) 1.8  (5.3)
10.Secondary Outcome
Title DLCO (%) (Diffusing Capacity of Carbon Monoxide) Change From Baseline
Hide Description [Not Specified]
Time Frame Day 1 (Baseline) and Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo PRM-151 1 mg/kg PRM-151 5 mg/kg PRM-151 10 mg/kg
Hide Arm/Group Description:
0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
Overall Number of Participants Analyzed 6 5 5 4
Mean (Standard Deviation)
Unit of Measure: Absolute change in % predicted DLCO
-2.3  (2.1) 0.2  (3.3) -4.0  (6.8) -1.5  (3.8)
11.Secondary Outcome
Title FEV1 (Forced Expiratory Volume 1sec )(%) Change From Baseline
Hide Description [Not Specified]
Time Frame Day 1 (Baseline) and Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo PRM-151 1 mg/kg PRM-151 5 mg/kg PRM-151 10 mg/kg
Hide Arm/Group Description:
0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
Overall Number of Participants Analyzed 6 5 5 4
Mean (Standard Deviation)
Unit of Measure: Absolute change in FEV1 % predicted
-1.7  (4.3) 2.6  (4.3) 2.4  (1.1) 0.3  (3.8)
12.Secondary Outcome
Title 6MWT (6 Minute Walk Test) Distance Walked Change From Baseline
Hide Description Change from baseline (measured during screening period) in distance walked during a 6 minute walk test
Time Frame Screening (between Day -35 and Day 1) and Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo PRM-151 1 mg/kg PRM-151 5 mg/kg PRM-151 10 mg/kg
Hide Arm/Group Description:
0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
Overall Number of Participants Analyzed 6 5 5 4
Mean (Standard Deviation)
Unit of Measure: meters
-11  (51) -11  (63) 6  (43) 35  (45)
13.Secondary Outcome
Title SGRQ (St. George's Respiratory Questionnaire) Total Score Change From Baseline
Hide Description St. George's Respiratory Questionnaire Total Score. Scores range from 0 (no impairment) to 100 (maximum impairment). A decrease in score represents a decrease in disease related symptoms. The SGRQ is not validated for IPF.
Time Frame Day 1 (Baseline) and Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo PRM-151 1 mg/kg PRM-151 5 mg/kg PRM-151 10 mg/kg
Hide Arm/Group Description:
0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
Overall Number of Participants Analyzed 6 5 5 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.5  (6.2) 2.3  (17.9) 7.1  (12.0) -6.3  (6.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo PRM-151 1 mg/kg PRM-151 5 mg/kg PRM-151 10 mg/kg
Hide Arm/Group Description 0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15 PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15 PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15 PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
All-Cause Mortality
Placebo PRM-151 1 mg/kg PRM-151 5 mg/kg PRM-151 10 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo PRM-151 1 mg/kg PRM-151 5 mg/kg PRM-151 10 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%)   0/5 (0.00%)   0/4 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo PRM-151 1 mg/kg PRM-151 5 mg/kg PRM-151 10 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   6/6 (100.00%)   5/5 (100.00%)   4/4 (100.00%) 
Blood and lymphatic system disorders         
Lymphadenopathy   1/6 (16.67%)  1/6 (16.67%)  0/5 (0.00%)  0/4 (0.00%) 
Gastrointestinal disorders         
Vomiting   2/6 (33.33%)  0/6 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
General disorders         
Fatigue   1/6 (16.67%)  0/6 (0.00%)  2/5 (40.00%)  1/4 (25.00%) 
Hematoma   1/6 (16.67%)  2/6 (33.33%)  0/5 (0.00%)  0/4 (0.00%) 
Catheter site hematoma   1/6 (16.67%)  1/6 (16.67%)  0/5 (0.00%)  0/4 (0.00%) 
Malaise   1/6 (16.67%)  1/6 (16.67%)  0/5 (0.00%)  0/4 (0.00%) 
Non-cardiac chest pain   2/6 (33.33%)  0/6 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Infections and infestations         
Nasopharyngitis   2/6 (33.33%)  1/6 (16.67%)  0/5 (0.00%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back pain   2/6 (33.33%)  0/6 (0.00%)  1/5 (20.00%)  0/4 (0.00%) 
Nervous system disorders         
Headache   1/6 (16.67%)  2/6 (33.33%)  0/5 (0.00%)  1/4 (25.00%) 
Dizziness   1/6 (16.67%)  1/6 (16.67%)  1/5 (20.00%)  0/4 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough   2/6 (33.33%)  4/6 (66.67%)  3/5 (60.00%)  0/4 (0.00%) 
Productive cough   2/6 (33.33%)  1/6 (16.67%)  2/5 (40.00%)  1/4 (25.00%) 
Dyspnoea   2/6 (33.33%)  2/6 (33.33%)  0/5 (0.00%)  0/4 (0.00%) 
Dyspnoea exertional   2/6 (33.33%)  1/6 (16.67%)  0/5 (0.00%)  0/4 (0.00%) 
Dysphonia   0/6 (0.00%)  2/6 (33.33%)  0/5 (0.00%)  0/4 (0.00%) 
Skin and subcutaneous tissue disorders         
Pruritus   1/6 (16.67%)  1/6 (16.67%)  1/5 (20.00%)  0/4 (0.00%) 
Vascular disorders         
Hypotension   0/6 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  1/4 (25.00%) 
Hypertension   1/6 (16.67%)  1/6 (16.67%)  0/5 (0.00%)  0/4 (0.00%) 
Indicates events were collected by systematic assessment
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.
Investigators agree that the first public presentation of data will be a joint, multicentre publication of results. If this does not occur within 12 months after conclusion of the study, investigator may publish the results, provided that the complete manuscript or other publication is submitted to the sponsor for review 30 days prior to submission.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Bernt van den Blink
Organization: Promedior, Inc.
Phone: 781-538-4203
EMail: bvandenblink@promedior.com
Layout table for additonal information
Responsible Party: Promedior, Inc.
ClinicalTrials.gov Identifier: NCT01254409    
Other Study ID Numbers: PRM151F-12GL
First Submitted: December 3, 2010
First Posted: December 6, 2010
Results First Submitted: April 11, 2014
Results First Posted: November 2, 2014
Last Update Posted: October 9, 2018