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Comparative Efficacy of 4 Oral Analgesics

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ClinicalTrials.gov Identifier: NCT02455518
Recruitment Status : Completed
First Posted : May 28, 2015
Results First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Andrew Chang, MD, Montefiore Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: Oxycodone/acetaminophen
Drug: Hydrocodone/acetaminophen
Drug: Codeine/acetaminophen
Drug: Ibuprofen/acetaminophen
Enrollment 416
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oxycodone/Acetaminophen Hydrocodone/Acetaminophen Codeine/Acetaminophen Ibuprofen/Acetaminophen
Hide Arm/Group Description

Oxycodone/acetaminophen (5 mg/325 mg)

Oxycodone/acetaminophen

Hydrocodone/acetaminophen (5 mg/300 mg)

Hydrocodone/acetaminophen

Codeine/acetaminophen (30 mg/300 mg)

Codeine/acetaminophen

Ibuprofen/acetaminophen (400 mg/1000 mg)

Ibuprofen/acetaminophen

Period Title: Overall Study
Started 104 104 104 104
Completed 104 103 103 101
Not Completed 0 1 1 3
Reason Not Completed
Protocol Violation             0             1             1             3
Arm/Group Title Oxycodone/Acetaminophen Hydrocodone/Acetaminophen Codeine/Acetaminophen Ibuprofen/Acetaminophen Total
Hide Arm/Group Description

Oxycodone/acetaminophen (5 mg/325 mg)

Oxycodone/acetaminophen

Hydrocodone/acetaminophen (5 mg/300 mg)

Hydrocodone/acetaminophen

Codeine/acetaminophen (30 mg/300 mg)

Codeine/acetaminophen

Ibuprofen/acetaminophen (400 mg/1000 mg)

Ibuprofen/acetaminophen

Total of all reporting groups
Overall Number of Baseline Participants 104 103 103 101 411
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 104 participants 103 participants 103 participants 101 participants 411 participants
37  (12) 37  (13) 37  (12) 37  (11) 37  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 103 participants 103 participants 101 participants 411 participants
Female
50
  48.1%
51
  49.5%
44
  42.7%
54
  53.5%
199
  48.4%
Male
54
  51.9%
52
  50.5%
59
  57.3%
47
  46.5%
212
  51.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 103 participants 103 participants 101 participants 411 participants
Latino
62
  59.6%
65
  63.1%
58
  56.3%
62
  61.4%
247
  60.1%
African-American
29
  27.9%
26
  25.2%
33
  32.0%
34
  33.7%
122
  29.7%
Caucasian
7
   6.7%
8
   7.8%
6
   5.8%
2
   2.0%
23
   5.6%
East Asian/Asian
2
   1.9%
3
   2.9%
3
   2.9%
3
   3.0%
11
   2.7%
Other
4
   3.8%
1
   1.0%
3
   2.9%
0
   0.0%
8
   1.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 104 participants 103 participants 103 participants 101 participants 411 participants
104 103 103 101 411
1.Primary Outcome
Title Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores
Hide Description Change in numerical rating scale (NRS) pre and 2 hours post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible)
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxycodone/Acetaminophen Hydrocodone/Acetaminophen Codeine/Acetaminophen Ibuprofen/Acetaminophen
Hide Arm/Group Description:

Oxycodone/acetaminophen (5 mg/325 mg)

Oxycodone/acetaminophen

Hydrocodone/acetaminophen (5 mg/300 mg)

Hydrocodone/acetaminophen

Codeine/acetaminophen (30 mg/300 mg)

Codeine/acetaminophen

Ibuprofen/acetaminophen (400 mg/1000 mg)

Ibuprofen/acetaminophen

Overall Number of Participants Analyzed 104 103 103 101
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: units on a scale
4.4
(3.7 to 5.0)
3.5
(2.9 to 4.2)
3.9
(3.2 to 4.5)
4.3
(3.6 to 4.9)
2.Secondary Outcome
Title Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores
Hide Description Change in numerical rating scale (NRS) pre and 1-hour post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible)
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxycodone/Acetaminophen Hydrocodone/Acetaminophen Codeine/Acetaminophen Ibuprofen/Acetaminophen
Hide Arm/Group Description:

Oxycodone/acetaminophen (5 mg/325 mg)

Oxycodone/acetaminophen

Hydrocodone/acetaminophen (5 mg/300 mg)

Hydrocodone/acetaminophen

Codeine/acetaminophen (30 mg/300 mg)

Codeine/acetaminophen

Ibuprofen/acetaminophen (400 mg/1000 mg)

Ibuprofen/acetaminophen

Overall Number of Participants Analyzed 104 103 103 101
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: units on a scale
3.1
(2.6 to 3.7)
2.4
(1.8 to 3.0)
2.7
(2.1 to 3.3)
2.9
(2.4 to 3.5)
Time Frame Adverse events were not collected
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oxycodone/Acetaminophen Hydrocodone/Acetaminophen Codeine/Acetaminophen Ibuprofen/Acetaminophen
Hide Arm/Group Description

Oxycodone/acetaminophen (5 mg/325 mg)

Oxycodone/acetaminophen

Hydrocodone/acetaminophen (5 mg/300 mg)

Hydrocodone/acetaminophen

Codeine/acetaminophen (30 mg/300 mg)

Codeine/acetaminophen

Ibuprofen/acetaminophen (400 mg/1000 mg)

Ibuprofen/acetaminophen

All-Cause Mortality
Oxycodone/Acetaminophen Hydrocodone/Acetaminophen Codeine/Acetaminophen Ibuprofen/Acetaminophen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Oxycodone/Acetaminophen Hydrocodone/Acetaminophen Codeine/Acetaminophen Ibuprofen/Acetaminophen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oxycodone/Acetaminophen Hydrocodone/Acetaminophen Codeine/Acetaminophen Ibuprofen/Acetaminophen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
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: Dr. Andrew Chang
Organization: Albany Medical College
Phone: 2125555555
EMail: achang3@yahoo.com
Layout table for additonal information
Responsible Party: Andrew Chang, MD, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02455518     History of Changes
Other Study ID Numbers: 2014-4156
First Submitted: May 22, 2015
First Posted: May 28, 2015
Results First Submitted: December 14, 2017
Results First Posted: February 13, 2018
Last Update Posted: February 13, 2018