Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery

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: NCT01888367
Recruitment Status : Completed
First Posted : June 27, 2013
Results First Posted : October 11, 2016
Last Update Posted : October 11, 2016
Sponsor:
Collaborator:
Duke Clinical Research Institute
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Prevention
Condition Surgical Site Infections
Interventions Drug: DFA-02 Antibiotic Gel
Drug: DFA-02 Placebo Gel
Enrollment 445
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DFA-02 Antibiotic Gel DFA-02 Placebo Gel Standard of Care
Hide Arm/Group Description

Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.

DFA-02 Antibiotic Gel

Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.

DFA-02 Placebo Gel

Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
Period Title: Overall Study
Started 296 71 78
Completed 288 66 73
Not Completed 8 5 5
Reason Not Completed
Physician Decision             3             4             2
Death             2             0             1
Withdrawal by Subject             1             0             1
Lost to Follow-up             1             1             0
Protocol Violation             0             0             1
30-Day Visit Too Early (< 28 Days)             1             0             0
Arm/Group Title DFA-02 Antibiotic Gel DFA-02 Placebo Gel Standard of Care Total
Hide Arm/Group Description

Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.

DFA-02 Antibiotic Gel

Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.

DFA-02 Placebo Gel

Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied. Total of all reporting groups
Overall Number of Baseline Participants 296 71 78 445
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 296 participants 71 participants 78 participants 445 participants
60.1  (14.6) 58.8  (15.7) 59.6  (14.7) 59.8  (14.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 296 participants 71 participants 78 participants 445 participants
Female
142
  48.0%
33
  46.5%
45
  57.7%
220
  49.4%
Male
154
  52.0%
38
  53.5%
33
  42.3%
225
  50.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 296 participants 71 participants 78 participants 445 participants
American Indian or Alaska Native
1
   0.3%
0
   0.0%
0
   0.0%
1
   0.2%
Asian
8
   2.7%
1
   1.4%
0
   0.0%
9
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
31
  10.5%
10
  14.1%
4
   5.1%
45
  10.1%
White
255
  86.1%
60
  84.5%
74
  94.9%
389
  87.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   0.3%
0
   0.0%
0
   0.0%
1
   0.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 296 participants 71 participants 78 participants 445 participants
296 71 78 445
1.Primary Outcome
Title Number of Patients With Surgical Site Infections
Hide Description [Not Specified]
Time Frame Within 30 days of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
The number of SSIs from the day of surgery to 30 days post-op could only be assessed in the 427 completed patients. Central adjudication by the Clinical Events Committee was not able to assess the presence or absence of SSI for two patients, one in the DFA-02 group and one in the SOC group so the total analyzed is only 425.
Arm/Group Title DFA-02 Antibiotic Gel DFA-02 Placebo Gel Standard of Care
Hide Arm/Group Description:

Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.

DFA-02 Antibiotic Gel

Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.

DFA-02 Placebo Gel

Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
Overall Number of Participants Analyzed 287 66 72
Measure Type: Number
Unit of Measure: participants
42 14 25
2.Secondary Outcome
Title Number of Patients With Adverse Events
Hide Description [Not Specified]
Time Frame Within 30 days of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the patients who did not receive gel were counted in the SOC group.
Arm/Group Title DFA-02 Antibiotic Gel DFA-02 Placebo Gel Standard of Care
Hide Arm/Group Description:

Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.

DFA-02 Antibiotic Gel

Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.

DFA-02 Placebo Gel

Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
Overall Number of Participants Analyzed 284 64 93
Measure Type: Number
Unit of Measure: participants
267 61 86
3.Secondary Outcome
Title Change in Serum Creatinine Measurements From Baseline
Hide Description Change from baseline in micromoles/liter
Time Frame Within 4 days of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
402 of the 445 patients had both baseline and post-operative creatinine measurements. Safety analyses were "as treated" so patients randomized to gel but did not receive it in surgery were counted in the SOC group.
Arm/Group Title DFA-02 Antibiotic Gel DFA-02 Placebo Gel Standard of Care
Hide Arm/Group Description:

Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.

DFA-02 Antibiotic Gel

Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.

DFA-02 Placebo Gel

Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
Overall Number of Participants Analyzed 262 61 79
Mean (Standard Deviation)
Unit of Measure: micromoles/liter
-10.2  (18.2) -9.9  (12.8) -10.2  (27.0)
4.Secondary Outcome
Title Cumulative ASEPSIS Score for Each Patient
Hide Description Total ASEPSIS score with a range of 0-65 points with lower scores being better. The score is the sum of: Antibiotic Use (10 points), Drainage of Pus Under Local Anesthesia (5 points), Debridement Under General Anesthesia (10 points), Serous Discharge (5 points), Erythema (5 points), Purulent Exudate (5 points), Separation of Deep Tissues (10 points) and Isolation of Bacteria from Discharge (10 points). Source: Wilson AP, Treasure T, Sturridge MF, Gruneberg RN. Lancet. 1986:1(8476):311-3.
Time Frame Through post-operative Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analyses were "as treated" so patients who were randomized to gel but did not receive it are counted as SOC. For 4 patients, the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized.
Arm/Group Title DFA-02 Antibiotic Gel DFA-02 Placebo Gel Standard of Care
Hide Arm/Group Description:

Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.

DFA-02 Antibiotic Gel

Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.

DFA-02 Placebo Gel

Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
Overall Number of Participants Analyzed 284 64 93
Mean (Standard Deviation)
Unit of Measure: units on a scale
17.5  (8.1) 18.5  (3.5) 23.0  (3.5)
Time Frame From time of surgery until 30 days post-op.
Adverse Event Reporting Description Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
 
Arm/Group Title DFA-02 Antibiotic Gel DFA-02 Placebo Gel Standard of Care
Hide Arm/Group Description

Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.

DFA-02 Antibiotic Gel

Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.

DFA-02 Placebo Gel

Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
All-Cause Mortality
DFA-02 Antibiotic Gel DFA-02 Placebo Gel Standard of Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
DFA-02 Antibiotic Gel DFA-02 Placebo Gel Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   59/284 (20.77%)      14/64 (21.88%)      21/93 (22.58%)    
Blood and lymphatic system disorders       
Anemia  1  1/284 (0.35%)  1 0/64 (0.00%)  0 1/93 (1.08%)  1
Leukocytosis  1  0/284 (0.00%)  0 1/64 (1.56%)  1 0/93 (0.00%)  0
Cardiac disorders       
Atrial Fibrillation  1  1/284 (0.35%)  1 0/64 (0.00%)  0 0/93 (0.00%)  0
Cardiac Arrest  1  1/284 (0.35%)  1 0/64 (0.00%)  0 0/93 (0.00%)  0
Myocardial Infarction  1  1/284 (0.35%)  1 0/64 (0.00%)  0 0/93 (0.00%)  0
Ventricular Tachycardia  1  1/284 (0.35%)  1 0/64 (0.00%)  0 0/93 (0.00%)  0
Gastrointestinal disorders       
Small Intestine Obstruction  1  4/284 (1.41%)  4 0/64 (0.00%)  0 1/93 (1.08%)  1
Enterocutaneous Fistula  1  3/284 (1.06%)  3 0/64 (0.00%)  0 1/93 (1.08%)  1
Ileus  1  2/284 (0.70%)  2 1/64 (1.56%)  1 1/93 (1.08%)  1
Gastrointestinal Hemorrhage  1  2/284 (0.70%)  2 0/64 (0.00%)  0 1/93 (1.08%)  1
Abdominal Wall Hematoma  1  1/284 (0.35%)  1 0/64 (0.00%)  0 1/93 (1.08%)  1
Abdominal Pain  1  0/284 (0.00%)  0 1/64 (1.56%)  1 0/93 (0.00%)  0
Intestinal Obstruction  1  0/284 (0.00%)  0 1/64 (1.56%)  1 0/93 (0.00%)  0
Intra-abdominal Hemorrhage  1  1/284 (0.35%)  1 0/64 (0.00%)  0 0/93 (0.00%)  0
Localized Abdominal Fluid Collection  1  1/284 (0.35%)  1 0/64 (0.00%)  0 0/93 (0.00%)  0
Nausea  1  1/284 (0.35%)  1 0/64 (0.00%)  0 0/93 (0.00%)  0
Pneumoperitoneum  1  0/284 (0.00%)  0 0/64 (0.00%)  0 1/93 (1.08%)  1
Rectal Hemorrhage  1  0/284 (0.00%)  0 0/64 (0.00%)  0 1/93 (1.08%)  1
Small Intestinal Perforation  1  1/284 (0.35%)  1 0/64 (0.00%)  0 0/93 (0.00%)  0
General disorders       
Asthenia  1  1/284 (0.35%)  1 0/64 (0.00%)  0 0/93 (0.00%)  0
Device Dislocation  1  1/284 (0.35%)  1 0/64 (0.00%)  0 0/93 (0.00%)  0
Systemic Inflammatory Response Syndrome  1  0/284 (0.00%)  0 0/64 (0.00%)  0 1/93 (1.08%)  1
Infections and infestations       
Pelvic Abscess  1  1/284 (0.35%)  1 4/64 (6.25%)  4 0/93 (0.00%)  0
Pneuomia  1  3/284 (1.06%)  3 1/64 (1.56%)  1 1/93 (1.08%)  1
Abdominal Abscess  1  1/284 (0.35%)  1 0/64 (0.00%)  0 3/93 (3.23%)  3
Abscess  1  2/284 (0.70%)  2 0/64 (0.00%)  0 0/93 (0.00%)  0
Peritonitis  1  2/284 (0.70%)  2 0/64 (0.00%)  0 0/93 (0.00%)  0
Wound Infection  1  0/284 (0.00%)  0 1/64 (1.56%)  1 1/93 (1.08%)  1
Abdominal Infection  1  1/284 (0.35%)  1 0/64 (0.00%)  0 0/93 (0.00%)  0
Abdominal Sepsis  1  1/284 (0.35%)  1 0/64 (0.00%)  0 0/93 (0.00%)  0
Clostridium difficile Infection  1  1/284 (0.35%)  1 0/64 (0.00%)  0 0/93 (0.00%)  0
Hematoma Infection  1  0/284 (0.00%)  0 0/64 (0.00%)  0 1/93 (1.08%)  1
Incision Site Infection  1  0/284 (0.00%)  0 0/64 (0.00%)  0 1/93 (1.08%)  1
Postoperative Wound Infection  1  1/284 (0.35%)  1 0/64 (0.00%)  0 0/93 (0.00%)  0
Sepsis  1  1/284 (0.35%)  1 0/64 (0.00%)  0 0/93 (0.00%)  0
Septic Shock  1  1/284 (0.35%)  1 0/64 (0.00%)  0 0/93 (0.00%)  0
Splenic Abscess  1  1/284 (0.35%)  1 0/64 (0.00%)  0 0/93 (0.00%)  0
Subdiaphragmatic Abscess  1  0/284 (0.00%)  0 1/64 (1.56%)  1 0/93 (0.00%)  0
Urinary Tract Infection  1  1/284 (0.35%)  1 0/64 (0.00%)  0 0/93 (0.00%)  0
Injury, poisoning and procedural complications       
Postoperative Ileus  1  7/284 (2.46%)  7 2/64 (3.13%)  2 4/93 (4.30%)  4
Anastomotic Leak  1  2/284 (0.70%)  2 1/64 (1.56%)  1 1/93 (1.08%)  1
Abdominal Wound Dehiscence  1  0/284 (0.00%)  0 0/64 (0.00%)  0 1/93 (1.08%)  1
Anastomotic Complication  1  0/284 (0.00%)  0 0/64 (0.00%)  0 1/93 (1.08%)  1
Bladder Injury  1  1/284 (0.35%)  1 0/64 (0.00%)  0 0/93 (0.00%)  0
Hip Fracture  1  1/284 (0.35%)  1 0/64 (0.00%)  0 0/93 (0.00%)  0
Postoperative Renal Failure  1  1/284 (0.35%)  1 0/64 (0.00%)  0 0/93 (0.00%)  0
Procedural Vomiting  1  1/284 (0.35%)  1 0/64 (0.00%)  0 0/93 (0.00%)  0
Splenic Rupture  1  1/284 (0.35%)  1 0/64 (0.00%)  0 0/93 (0.00%)  0
Wound Secretion  1  0/284 (0.00%)  0 1/64 (1.56%)  1 0/93 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration  1  6/284 (2.11%)  6 0/64 (0.00%)  0 1/93 (1.08%)  1
Failure to Thrive  1  0/284 (0.00%)  0 0/64 (0.00%)  0 1/93 (1.08%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Rectal Cancer Metastatic  1  0/284 (0.00%)  0 0/64 (0.00%)  0 1/93 (1.08%)  1
Renal Cell Carcinoma  1  0/284 (0.00%)  0 0/64 (0.00%)  0 1/93 (1.08%)  1
Psychiatric disorders       
Mental Status Changes  1  1/284 (0.35%)  1 0/64 (0.00%)  0 0/93 (0.00%)  0
Renal and urinary disorders       
Acute Kidney Injury  1  1/284 (0.35%)  1 0/64 (0.00%)  0 2/93 (2.15%)  2
Reproductive system and breast disorders       
Pelvic Pain  1  1/284 (0.35%)  1 0/64 (0.00%)  0 0/93 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Acute Respiratory Failure  1  3/284 (1.06%)  3 0/64 (0.00%)  0 1/93 (1.08%)  1
Pulmonary Embolism  1  3/284 (1.06%)  3 1/64 (1.56%)  1 0/93 (0.00%)  0
Respiratory Failure  1  3/284 (1.06%)  3 0/64 (0.00%)  0 0/93 (0.00%)  0
Chronic Obstructive Pulmonary Disease  1  1/284 (0.35%)  1 0/64 (0.00%)  0 0/93 (0.00%)  0
Pneumonia Aspiration  1  0/284 (0.00%)  0 0/64 (0.00%)  0 1/93 (1.08%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DFA-02 Antibiotic Gel DFA-02 Placebo Gel Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   267/284 (94.01%)      61/64 (95.31%)      86/93 (92.47%)    
Blood and lymphatic system disorders       
Leukocytosis  1  29/284 (10.21%)  29 6/64 (9.38%)  6 12/93 (12.90%)  12
Anemia  1  24/284 (8.45%)  24 4/64 (6.25%)  4 10/93 (10.75%)  10
Cardiac disorders       
Tachycardia  1  46/284 (16.20%)  46 14/64 (21.88%)  14 15/93 (16.13%)  15
Gastrointestinal disorders       
Nausea  1  118/284 (41.55%)  118 32/64 (50.00%)  32 41/93 (44.09%)  41
Vomiting  1  39/284 (13.73%)  39 15/64 (23.44%)  15 11/93 (11.83%)  11
Diarrhea  1  25/284 (8.80%)  25 1/64 (1.56%)  1 3/93 (3.23%)  3
Dyspepsia  1  17/284 (5.99%)  17 4/64 (6.25%)  4 2/93 (2.15%)  2
Constipation  1  14/284 (4.93%)  14 4/64 (6.25%)  4 1/93 (1.08%)  1
Abdominal Distention  1  10/284 (3.52%)  10 3/64 (4.69%)  3 5/93 (5.38%)  5
General disorders       
Pyrexia  1  30/284 (10.56%)  30 6/64 (9.38%)  6 7/93 (7.53%)  7
Infections and infestations       
Incision Site Infection  1  17/284 (5.99%)  17 3/64 (4.69%)  3 4/93 (4.30%)  4
Pelvic Abscess  1  2/284 (0.70%)  2 4/64 (6.25%)  4 0/93 (0.00%)  0
Injury, poisoning and procedural complications       
Procedural Pain  1  143/284 (50.35%)  143 32/64 (50.00%)  32 52/93 (55.91%)  52
Procedural Nausea  1  28/284 (9.86%)  28 8/64 (12.50%)  8 10/93 (10.75%)  10
Anemia Postoperative  1  26/284 (9.15%)  26 6/64 (9.38%)  6 12/93 (12.90%)  12
Incision Site Pain  1  17/284 (5.99%)  17 3/64 (4.69%)  3 3/93 (3.23%)  3
Postoperative Ileus  1  12/284 (4.23%)  12 3/64 (4.69%)  3 4/93 (4.30%)  4
Seroma  1  12/284 (4.23%)  12 5/64 (7.81%)  5 0/93 (0.00%)  0
Investigations       
Urine Output Decreased  1  26/284 (9.15%)  26 5/64 (7.81%)  5 10/93 (10.75%)  10
Oxygen Saturation Decreased  1  16/284 (5.63%)  16 3/64 (4.69%)  3 6/93 (6.45%)  6
Amylase Decreased  1  3/284 (1.06%)  3 0/64 (0.00%)  0 5/93 (5.38%)  5
Metabolism and nutrition disorders       
Hyperglycemia  1  46/284 (16.20%)  46 8/64 (12.50%)  8 18/93 (19.35%)  18
Hypokalemia  1  43/284 (15.14%)  43 7/64 (10.94%)  7 17/93 (18.28%)  17
Hypophosphatemia  1  39/284 (13.73%)  39 9/64 (14.06%)  9 14/93 (15.05%)  14
Hypocalcemia  1  37/284 (13.03%)  37 7/64 (10.94%)  7 15/93 (16.13%)  15
Hypomagnesemia  1  25/284 (8.80%)  25 5/64 (7.81%)  5 12/93 (12.90%)  12
Hypoproteinemia  1  26/284 (9.15%)  26 4/64 (6.25%)  4 10/93 (10.75%)  10
Hypoalbuminemia  1  28/284 (9.86%)  28 2/64 (3.13%)  2 8/93 (8.60%)  8
Hyponatremia  1  19/284 (6.69%)  19 4/64 (6.25%)  4 8/93 (8.60%)  8
Hypochloremia  1  14/284 (4.93%)  14 1/64 (1.56%)  1 5/93 (5.38%)  5
Nervous system disorders       
Headache  1  17/284 (5.99%)  17 3/64 (4.69%)  3 5/93 (5.38%)  5
Psychiatric disorders       
Anxiety  1  19/284 (6.69%)  19 2/64 (3.13%)  2 7/93 (7.53%)  7
Insomnia  1  15/284 (5.28%)  15 2/64 (3.13%)  2 9/93 (9.68%)  9
Renal and urinary disorders       
Hematuria  1  12/284 (4.23%)  12 8/64 (12.50%)  8 8/93 (8.60%)  8
Urinary Retention  1  14/284 (4.93%)  14 4/64 (6.25%)  4 9/93 (9.68%)  9
Respiratory, thoracic and mediastinal disorders       
Oropharyngeal Pain  1  28/284 (9.86%)  28 7/64 (10.94%)  7 3/93 (3.23%)  3
Skin and subcutaneous tissue disorders       
Pruritus  1  42/284 (14.79%)  42 9/64 (14.06%)  9 15/93 (16.13%)  15
Vascular disorders       
Hypertension  1  34/284 (11.97%)  34 7/64 (10.94%)  7 6/93 (6.45%)  6
Hypotension  1  23/284 (8.10%)  23 2/64 (3.13%)  2 9/93 (9.68%)  9
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.0)
The number of culture positive SSIs were too small to draw any conclusions on antibiotic resistance.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: VP, Drug Development
Organization: Promius Pharma, LLC, Dr. Reddy's Laboratories
Phone: 609-375-9855
EMail: kallenby@drreddys.com
Layout table for additonal information
Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01888367    
Other Study ID Numbers: DFA-02-CD-005
First Submitted: June 25, 2013
First Posted: June 27, 2013
Results First Submitted: March 23, 2016
Results First Posted: October 11, 2016
Last Update Posted: October 11, 2016