Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study

Pain Clinical Trial

Official title:

Randomized, Double-Blind, Placebo And Active Controlled, Study To Evaluate Two Strengths Of Concomitantly Dosed Naproxen Sodium With Acetaminophen, Compared With Naproxen Sodium and Hydrocodone/Acetaminophen In Postoperative Dental Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03879408
• Other study ID #: CCSPAA001068
• Status: Completed
• Phase: Phase 2
• Start date: May 28, 2019
• Est. completion date: November 13, 2019

Study information

• Verified date: November 2022
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study assessing efficacy and safety of concomitantly dosed naproxen sodium with acetaminophen, compared with naproxen sodium, hydrocodone/acetaminophen and Placebo in a postoperative dental pain.

Description:

This is a randomized, double-blind, placebo- and active-controlled, parallel-group study to evaluate the analgesic efficacy and safety of concomitantly administered naproxen sodium 440 mg with acetaminophen 1000 mg and concomitantly administered naproxen sodium 220 mg with acetaminophen 650 mg, compared with a fixed combination of hydrocodone 10 mg/acetaminophen 650 mg, naproxen sodium 440 mg, and placebo over a twelve-hour period after surgical extraction of four third molars.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: November 13, 2019
• Est. primary completion date: November 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Males of females 17-50 years old

2. Weigh 100 pounds or greater and have a body mass index (BMI) of 18.5 to 35 (inclusive) at screening

3. Surgical removal of up to four third molars, of which, two must be mandibular impactions

4. Meets requirements for post -surgical pain level

5. Females of childbearing potential and males agree to contraceptive requirements of study

6. Have a negative urine drug screen at screening, and on day of surgical procedure

Exclusion Criteria:

1. Pregnant female, breastfeeding, trying to become pregnant or male with pregnant partner or partner currently trying to become pregnant

2. Have known allergy or hypersensitivity to naproxen or other NSAIDS, including aspirin, or to acetaminophen, tramadol, hydrocodone or other opioids

3. Not able to swallow large tablets or capsules

4. History of any condition (s) in investigator's opinion, may jeopardize subject safety, well-being and integrity of study

5. Use analgesics 5 or more times per week

6. History of chronic tranquilizer use, heavy drinking, substance abuse as judged by investigator site staff within last 5 years

7. Use of immunosuppressive drugs within 2 weeks of screening

8. History of peptic ulcer disease or gastrointestinal bleeding in the last two years or hematologic bleeding

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• 440 mg naproxen sodium with 1000 mg acetaminophen
440 mg naproxen sodium with 1000 mg acetaminophen administered as a single dose of two naproxen sodium 220 mg tablets and two acetaminophen 500 mg tablets
• 220 mg naproxen sodium with 650 mg acetaminophen
220 mg naproxen sodium with 650 mg acetaminophen administered as a single dose of one naproxen sodium 220 mg tablet and two acetaminophen 325 mg tablets and one placebo tablet
• 10 mg hydrocodone + 650 mg acetaminophen
10 mg hydrocodone with 650 mg acetaminophen administered as a single dose of two hydrocodone 5 mg + acetaminophen 325 mg tablets and two placebo tablets
• 440 mg naproxen sodium
440 mg naproxen sodium administered as a single dose of two naproxen sodium 220 mg tablets and two placebo tablets
• Placebo tablet
Single dose of four placebo tablets

Locations

Country	Name	City	State
United States	Jean Brown Research Clinical Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 6 Hours (SPID 0-6)	Time-weighted sum of the pain intensity difference (SPID) score was measured using a Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain). The possible range of SPID for 0-6 hours was from -60 to 60. A higher value of SPID indicated greater pain relief. PID was the difference between baseline pain intensity and pain intensity at assessment. Time-weighted sum of the pain intensity difference scores were derived by first multiplying each PID score by the time from the previous time point and adding these time-weighted PID scores together over the intervals from 0 to 6 hours.	Baseline (0 hour) up to 6 hours post-dose
Primary	Time-weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 12 Hours (SPID 0-12)	Time-weighted sum of the pain intensity difference score was measured using a PI-NRS ranging from 0-10 (0 = no pain, 10 = very severe pain). The possible range of SPID for 0-12 hours was from -120 to 120. A higher value of SPID indicated greater pain relief. PID was the difference between baseline pain intensity and pain intensity at assessment (12 hours). Time-weighted sum of the pain intensity difference scores were derived by first multiplying each PID score by the time from the previous time point and adding these time-weighted PID scores together over the intervals from 0 to 12 hours.	Baseline (0 hour) up to 12 hours post-dose
Secondary	Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 6 Hours (TOTPAR 0-6)	Time-weighted total pain relief (TOTPAR) was measured using a Pain Relief Numerical Rating Scale (PR-NRS) ranging from 0-10 (0 = no relief, 10 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value was 0, and the maximum value was 60. Higher scores was indicative of more pain relief.	Baseline (0 hour) up to 6 hours post-dose
Secondary	Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 8 Hours (TOTPAR 0-8)	TOTPAR was measured using a PR-NRS ranging from 0-10 (0 = no relief, 10 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value was 0, and the maximum value was 80. Higher scores was indicative of more pain relief.	Baseline (0 hour) up to 8 hours post-dose
Secondary	Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 12 Hours (TOTPAR 0-12)	TOTPAR was measured using a PR-NRS ranging from 0-10 (0 = no relief, 10 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value was 0, and the maximum value was 120. Higher scores was indicative of more pain relief.	Baseline (0 hour) up to 12 hours post-dose
Secondary	Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 8 Hours (SPID 0-8)	Time-weighted sum of the pain intensity difference score was measured using a PI-NRS ranging from 0-10 (0 = no pain, 10 = very severe pain). The possible range of SPID for 0-8 hours was from -80 to 80. A higher value of SPID indicated greater pain relief. PID was the difference between baseline pain intensity and pain intensity at assessment (8 hours). Time-weighted sum of the pain intensity difference scores were derived by first multiplying each PID score by the time from the previous time point and adding these time-weighted PID scores together over the intervals from 0 to 8 hours.	Baseline (0 hour) up to 8 hours post-dose
Secondary	Pain Relief (PAR) Scores at Individual Timepoints	Participants answered a question at individual time points: "how much relief do you have from your starting pain?" on a 11-point PR-NRS. Scale ranged from 0=no relief to 10=complete relief. Higher score indicated improvement in pain.	0.25 hours, 0.5 hours, 0.75 hours, 1 hours, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, and 12 hours
Secondary	Pain Intensity Difference (PID) Scores at Individual Time Points	Pain Intensity was self-reported over 12 hours, using a pain rating of 0-10 on the PI-NRS, with score ranged from 0-10 (0= no pain; 10 = worst imaginable pain). Pain intensity differences were calculated with respect to baseline at each time point after study drug administration.	0.25 hours, 0.5 hours, 0.75 hours, 1 hours, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, and 12 hours
Secondary	Participant's Global Evaluation of Study Medication OR Overall Impression of Study Medication According to Participant's Global Evaluation	Participants were asked to rate their overall impression of the study medication using the following scale: poor (0), fair (1), good (2), very good (3), and excellent (4) where higher score represented better outcome.	Up to 12 hours