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The phase II, 12-h, double-blind, five-arm, parallel-group, in-patient, placebo-controlled study aimed to examine the overall analgesic efficacy of three different FDCs of IBU/APAP compared with IBU 400 mg and placebo for post-surgical dental pain.
The study investigated the effects of FDCs (fixed-dose combinations) of
ibuprofen/acetaminophen (IBU/APAP) for post-surgical dental pain depicted that
each of the tested FDCs provided analgesia that was similar to that with IBU
400 mg and superior to that with placebo. Each FDC provided MPR (meaningful
pain relief) in < 1h, and duration of pain relief > 9 h. All the FDCs
were generally well-tolerated, with an adverse event profile similar to that of
both placebo and IBU 400mg.
The phase II, 12-h, double-blind, five-arm, parallel-group, in-patient,
placebo-controlled study aimed to examine the overall analgesic efficacy of
three different FDCs of IBU/APAP compared with IBU 400 mg and placebo for
post-surgical dental pain.
A total of 576 patients were screened, and 394 patients were randomized. In patients with moderate-to-severe pain following third molar extraction, the study compared three FDCs of IBU/APAP (200 mg/500 mg, 250 mg/500 mg, and 300 mg/500 mg) with IBU 400 mg and placebo. The primary efficacy endpoint measured was SPRID[4]0–8 (time-weighted sum of pain relief and pain intensity difference scores from 0 to 8 h after dosing). The duration of pain relief, AEs (adverse events), TMPR (Time to meaningful pain relief) were also estimated.
All the active treatments were found to be superior to
placebo for SPRID[4]0–8 but
not significantly different from ibuprofen 400 mg. The median TMPR with the
FDCs IBU/APAP formulations ranged from 44.5 to 54.1 minutes compared with 56.2
min with IBU 400 mg and >720 min with placebo.
The median time to treatment failure with placebo was 1.6 h,
whereas a similar median time to treatment failure was found with all the three
FDCs (9.7, 10.1, and 11.1 h). Results for the FDCs were not considerably
different from IBU 400 mg (10.4 h) as depicted in Table 1:
|
Variable |
FDC ibuprofen/acetaminophen |
Ibuprofen 400 mg (n=92) |
Placebo (n=30) |
||
|
200 mg/500 mg (n=90) |
250 mg/500 mg (n=93) |
300 mg/500 mg (n=89) |
|||
|
Median time to meaningful
pain relief (min) |
44.5 |
54.1 |
45.9 |
56.2 |
>720 |
|
Median time to treatment failure (hours) |
9.7 |
10.1 |
11.1 |
10.4 |
1.6 |
Table 1: Median Time to meaningful pain relief and treatment failure for the groups
The overall incidence of AE was comparable among all the treatment groups.
For postsurgical
dental pain, the FDCs of IBU/APAP has a safety and efficacy profile comparable
to that of IBU 400 mg.
Drugs in R&D
Evaluation of Fixed-Dose Combinations of Ibuprofen and Acetaminophen in the Treatment of Postsurgical Dental Pain: A Pilot, Dose-Ranging, Randomized Study
David Kellstein
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