GEMINI SDDP
Alternative name: B5061003,
ID: 6715b6d8307678db2cf79146
3 Documents
Close
3 References ( articles) loading Revert Studify

Primary study

Unclassified

A Safety And Efficacy Study of Ibuprofen 250 mg / Acetaminophen 500 mg In The Treatment Of Post-Surgical Dental Pain

Autoren Pfizer
Registry of Trials clinicaltrials.gov
Year 2015
Links Registry of Trials
Loading references information
This is a randomized, double blind, placebo-controlled, parallel group, single-center study in approximately 560 subjects to determine the overall analgesic efficacy and safety of a fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to ibuprofen 250 mg alone, acetaminophen 650 mg alone, and to placebo. Subjects will be healthy males and females aged 18-40 years, inclusive, who are experiencing post-operative pain following surgical extraction of 3 or more third molar teeth. Following extraction, subjects must experience, within 5 hours, post-surgical pain of at least moderate severity (on a 4-point categorical scale), confirmed by a Visual Analog Pain Severity Rating Scale (VAS PSR) of at least 50 mm on a 100 mm VAS PSR scale. Eligible subjects will be randomized to receive a single oral dose of study medication under double-blind conditions and then evaluated on site for 12 hours following administration of study medication. Subjects will provide self-ratings of pain severity and pain relief at various time points using categorical and numerical scales. Additionally, subjects will also evaluate the time to first perceptible relief and time to meaningful relief using a double stopwatch method. Finally, at 12 hours, subjects will complete a categorical Global Evaluation of the study medication. A review of any reported adverse events will also be completed.

Primary study

Unclassified

Efficacy and safety of single and multiple doses of a fixed-dose combination of ibuprofen and acetaminophen in the treatment of postsurgical dental pain: results from two phase 3, randomized, parallel-group, double-blind, placebo-controlled studies

Zeitung Clinical journal of pain
Year 2020

This article is not included in any systematic review

Loading references information
OBJECTIVES: A previous pilot study demonstrated that various fixed‐dose combinations (FDCs) of ibuprofen (IBU) and acetaminophen (APAP) provided analgesic efficacy comparable to a higher dose of IBU, with the same safety profile. These studies further evaluated the chosen FDC IBU/APAP 250mg/500mg formulation. METHOD(S): Two phase 3 dental pain studies enrolled healthy young patients with >=moderate pain after >=3 third molar extractions who received single‐dose FDC IBU/APAP 250mg/500mg, IBU 250mg, APAP 650mg, or placebo evaluated over 12 hours (Study 1) or multiple‐dose FDC or placebo every 8 hours, evaluated over 48 hours (Study 2). Time‐weighted sum of pain intensity differences over 8 (SPID[11]0‐8) and 24 (SPID[11]0‐24) hours were primary outcomes, respectively. Time to meaningful pain relief (TMPR) and duration of pain relief were assessed; tolerability was evaluated by adverse events (AEs). RESULT(S): 568 patients were randomized in Study 1; 123 in Study 2. Study 1: SPID[11]0‐8 favored FDC significantly over placebo, IBU, and APAP (P<0.001, P=0.008, and P<0.001, respectively); Study 2: SPID[11]0‐24 significantly favored FDC over placebo (P<0.001), with sustained efficacy during multiple dosing. TMPR occurred within 1 hour; pain relief duration was >8 hours in both studies. AE rates were lowest with the FDC. DISCUSSION: FDC IBU/APAP 250mg/500mg provides superior analgesic efficacy to individual monocomponents (IBU 250mg and APAP 650mg), a rapid onset of action, >8‐hour duration of pain relief, is generally well tolerated, and may provide an additional nonopioid treatment option for acute pain.

Primary study

Unclassified

Efficacy and Safety of Single and Multiple Doses of a Fixed-dose Combination of Ibuprofen and Acetaminophen in the Treatment of Postsurgical Dental Pain: Results From 2 Phase 3, Randomized, Parallel-group, Double-blind, Placebo-controlled Studies.

Zeitung The Clinical journal of pain
Year 2020
Links Pubmed DOI

Dieser Artikel ist in enthalten 1 Systematic review Systematic reviews (1 reference)

Loading references information
<b>OBJECTIVES: </b>A previous pilot study demonstrated that various fixed-dose combinations (FDCs) of ibuprofen (IBU) and acetaminophen (APAP) provided analgesic efficacy comparable to a higher dose of IBU, with the same safety profile. These studies further evaluated the chosen FDC IBU/APAP 250/500 mg formulation.<b>MATERIALS AND METHODS: </b>Two phase 3 dental pain studies enrolled healthy young patients with ≥moderate pain after ≥3 third molar extractions who received single-dose FDC IBU/APAP 250/500 mg, IBU 250 mg, APAP 650 mg, or placebo evaluated over 12 hours (study 1) or multiple-dose FDC or placebo every 8 hours, evaluated over 48 hours (study 2). Time-weighted sum of pain intensity differences over 8 (SPID[11]0-8) and 24 (SPID[11]0-24) hours were primary outcomes, respectively. Time to meaningful pain relief and duration of pain relief were assessed; tolerability was evaluated by adverse events.<b>RESULTS: </b>Five hundred sixty-eight patients were randomized in study 1; 123 in study 2. Study 1: SPID[11]0-8 favored FDC significantly over placebo, IBU, and APAP (P&lt;0.001, P=0.008, and P&lt;0.001, respectively); study 2: SPID[11]0-24 significantly favored FDC over placebo (P&lt;0.001), with sustained efficacy during multiple dosing. Time to meaningful pain relief occurred within 1 hour; pain relief duration was &gt;8 hours in both studies. Adverse event rates were lowest with the FDC.<b>DISCUSSION: </b>FDC IBU/APAP 250/500 mg provides superior analgesic efficacy to individual monocomponents (IBU 250 mg and APAP 650 mg), a rapid onset of action, &gt;8-hour duration of pain relief, is generally well tolerated, and may provide an additional nonopioid treatment option for acute pain.