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PO vs. IV Acetaminophen Given Perioperatively for 24 hr Post-op Pain Control Following Total Hip or Knee Replacement (KHEA)

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ClinicalTrials.gov Identifier: NCT02244619
Recruitment Status : Completed
First Posted : September 19, 2014
Results First Posted : July 24, 2017
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
Kettering Health Network

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Post-op Pain
Interventions Drug: Oral acetaminophen
Drug: IV acetaminophen
Enrollment 515
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oral Acetaminophen IV Acetaminophen
Hide Arm/Group Description

Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.

Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.

Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.

IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.

Period Title: Overall Study
Started 249 266
Completed 241 245
Not Completed 8 21
Reason Not Completed
Did not receive study intervention             8             21
Arm/Group Title Oral Acetaminophen IV Acetaminophen Total
Hide Arm/Group Description

Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.

Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.

Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.

IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.

Total of all reporting groups
Overall Number of Baseline Participants 241 245 486
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 241 participants 245 participants 486 participants
67.0
(59.5 to 73.0)
67.0
(60.0 to 72.5)
67.0
(60.0 to 73.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 241 participants 245 participants 486 participants
Female
148
  61.4%
140
  57.1%
288
  59.3%
Male
93
  38.6%
105
  42.9%
198
  40.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 241 participants 245 participants 486 participants
Hispanic or Latino
2
   0.8%
5
   2.0%
7
   1.4%
Not Hispanic or Latino
237
  98.3%
240
  98.0%
477
  98.1%
Unknown or Not Reported
2
   0.8%
0
   0.0%
2
   0.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 241 participants 245 participants 486 participants
American Indian or Alaska Native
2
   0.8%
0
   0.0%
2
   0.4%
Asian
0
   0.0%
3
   1.2%
3
   0.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   1.2%
11
   4.5%
14
   2.9%
White
234
  97.1%
230
  93.9%
464
  95.5%
More than one race
0
   0.0%
1
   0.4%
1
   0.2%
Unknown or Not Reported
2
   0.8%
0
   0.0%
2
   0.4%
Taking medications for chronic pain  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 241 participants 245 participants 486 participants
214
  88.8%
212
  86.5%
426
  87.7%
Oxford score (hip or knee as appropriate)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 241 participants 245 participants 486 participants
20.76  (7.5) 20.19  (7.8) 20.47  (7.6)
[1]
Measure Description:

12-item ordinal scales. Each item ranges from 0 (high impairment) to 4 (no impairment). Total score ranges from 0-48 with following interpretation:

0-19: May indicate severe arthritis.

20-29: May indicate moderate to severe arthritis.

30-39: May indicate mild to moderate arthritis.

40-48: May indicate satisfactory joint function.

Body mass index   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Lb/in^2x703
Number Analyzed 241 participants 245 participants 486 participants
31.9
(28.3 to 37.08)
32.3
(28.5 to 36.71)
32.1
(28.4 to 36.8)
[1]
Measure Description: In the study data, BMI ranged from 19 (minimum) to 56 (maximum).
Diabetes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 241 participants 245 participants 486 participants
48
  19.9%
50
  20.4%
98
  20.2%
Stroke  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 241 participants 245 participants 486 participants
5
   2.1%
4
   1.6%
9
   1.9%
Type of surgery  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 241 participants 245 participants 486 participants
Knee
168
  69.7%
170
  69.4%
338
  69.5%
Hip
73
  30.3%
75
  30.6%
148
  30.5%
Pre-operative opioid  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 241 participants 245 participants 486 participants
50
  20.7%
57
  23.3%
107
  22.0%
Pre-operative Celecoxib  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 241 participants 245 participants 486 participants
198
  82.2%
195
  79.6%
393
  80.9%
Pre-operative Pregabalin  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 241 participants 245 participants 486 participants
230
  95.4%
232
  94.7%
462
  95.1%
Intra-operative total opioid  
Median (Inter-Quartile Range)
Unit of measure:  Morphine milligram equivalents (MME)
Number Analyzed 241 participants 245 participants 486 participants
10.0
(6.7 to 16.7)
10.0
(6.7 to 15.0)
10.0
(6.7 to 15.0)
Intra-operative Ketorolac  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 241 participants 245 participants 486 participants
35
  14.5%
36
  14.7%
71
  14.6%
Intra-operative Bupivacaine Liposome Injectable Suspension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 241 participants 245 participants 486 participants
163
  67.6%
162
  66.1%
325
  66.9%
1.Primary Outcome
Title Total Post-operative Use of Opioids
Hide Description Post-operative use of opioids, measured in morphine milligram equivalent (MME) units
Time Frame During post-op period up to 24 hrs after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Acetaminophen IV Acetaminophen
Hide Arm/Group Description:

Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.

Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.

Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.

IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.

Overall Number of Participants Analyzed 241 245
Median (Inter-Quartile Range)
Unit of Measure: Morphine milligram equivalents (MME)
21.7
(12.5 to 33.6)
21.7
(11.3 to 34.4)
2.Secondary Outcome
Title Patient-rated Pain in the Post-operative Period
Hide Description Patient-rated pain in the post-operative period was collected using a 10-point visual analog scale (VAS). A score of 0 indicates no pain; higher scores indicate greater pain. Minimum score for each VAS measurement is 0; Maximum score for each VAS measurement is 10. VAS scores were averaged for each patient.
Time Frame Standard-of-care post-op assessment intervals during post-op period up to 24 hrs after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Acetaminophen IV Acetaminophen
Hide Arm/Group Description:

Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.

Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.

Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.

IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.

Overall Number of Participants Analyzed 241 245
Median (Inter-Quartile Range)
Unit of Measure: Visual analog pain scale (0-10)
3.6
(2.4 to 5.0)
3.4
(2.1 to 4.8)
3.Other Pre-specified Outcome
Title Post-operative Nausea and Vomiting
Hide Description [Not Specified]
Time Frame During post-op period up to 24 hrs after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Acetaminophen IV Acetaminophen
Hide Arm/Group Description:

Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.

Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.

Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.

IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.

Overall Number of Participants Analyzed 241 245
Measure Type: Count of Participants
Unit of Measure: Participants
Nausea
51
  21.2%
53
  21.6%
Vomiting
19
   7.9%
17
   6.9%
4.Other Pre-specified Outcome
Title Time to First Ambulation - 10 Feet
Hide Description [Not Specified]
Time Frame During post-op period up to 24 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Acetaminophen IV Acetaminophen
Hide Arm/Group Description:

Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.

Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.

Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.

IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.

Overall Number of Participants Analyzed 241 245
Median (Inter-Quartile Range)
Unit of Measure: Hours
18.5
(13.8 to 21.3)
18.8
(15.1 to 21.0)
5.Other Pre-specified Outcome
Title Time to First Rescue Opioid (PRN Order)
Hide Description [Not Specified]
Time Frame During post-op period up to 24 hrs after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Acetaminophen IV Acetaminophen
Hide Arm/Group Description:

Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.

Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.

Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.

IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.

Overall Number of Participants Analyzed 241 245
Median (Inter-Quartile Range)
Unit of Measure: Minutes
38.0
(20.5 to 151.0)
41.0
(19.0 to 151.0)
6.Post-Hoc Outcome
Title Post-Anesthesia Care Unit (PACU) Length of Stay, Hours
Hide Description PACU length of stay was calculated as (PACU discharge moment - PACU admit moment). PACU length of stay is reported in hours.
Time Frame PACU admission time until PACU discharge time
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Acetaminophen IV Acetaminophen
Hide Arm/Group Description:

Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.

Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.

Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.

IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.

Overall Number of Participants Analyzed 241 245
Median (Inter-Quartile Range)
Unit of Measure: Hours
2.2
(1.7 to 2.7)
2.1
(1.7 to 2.6)
7.Post-Hoc Outcome
Title Hospital Length of Stay (LOS)
Hide Description Total hospital length of stay was calculated as (hospital discharge moment - hospital admission moment). Hospital length of stay is reported in hours.
Time Frame Pre-op admission to hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Acetaminophen IV Acetaminophen
Hide Arm/Group Description:

Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.

Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.

Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.

IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.

Overall Number of Participants Analyzed 241 245
Median (Inter-Quartile Range)
Unit of Measure: Hours
58.0
(55.6 to 79.6)
58.5
(55.5 to 80.9)
Time Frame AE/SAE monitoring started at first study drug dose and ended when subjects were discharged from the Post-Anesthesia Care Unit. The time period varied among subjects but was never more than 24 hours total.
Adverse Event Reporting Description Since both the PO and IV forms of the study drug are FDA approved, both are being used within approved labeling, and the study is not being conducted under an Investigational New Drug (IND) application, only events that meet Kettering Health Network’s criteria for reporting within the institution’s S.A.F.E. reporting system will be reported as SAEs or UPs.
 
Arm/Group Title Oral Acetaminophen IV Acetaminophen
Hide Arm/Group Description

Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.

Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.

Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.

IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.

All-Cause Mortality
Oral Acetaminophen IV Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/241 (0.00%)   0/245 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Oral Acetaminophen IV Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/241 (0.00%)   0/245 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oral Acetaminophen IV Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/241 (0.00%)   0/245 (0.00%) 
Single hospital, limited to two types of surgical patient. No standard protocol for assessing pain. Oral acetaminophen administered earlier than IV per hospital protocol.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Skip Hickman, RPH
Organization: Kettering Health Network
Phone: (937) 762-1339
EMail: skip.hickman@ketteringhealth.org
Layout table for additonal information
Responsible Party: Kettering Health Network
ClinicalTrials.gov Identifier: NCT02244619     History of Changes
Other Study ID Numbers: KMCPH-13-001
First Submitted: September 16, 2014
First Posted: September 19, 2014
Results First Submitted: May 17, 2017
Results First Posted: July 24, 2017
Last Update Posted: July 24, 2017