Clinical trial NCT01420653
Conditions: Dental Pain
Sponsor: AFT Pharmaceuticals, Ltd.
Start date: 2013-04-01; Completion date: 2015-01-01
Enrollment: 408 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the analgesic effects of Maxigesic USA are greater than acetaminophen, ibuprofen or placebo.

Detailed description:
The combination of 500mg acetaminophen and 150mg ibuprofen has been shown to improve analgesia compared with the individual components, when given as 2 tablets (i.e. total of 1,000/300 mg) 4 times a day.

Recent concerns over the safety of acetaminophen have led to some regulatory agencies restricting the maximum dose of acetaminophen per tablet to 325 mg, while maintaining the maximum daily dose of 4000mg per day.

A dosing regimen of three tablets of Maxigesic 325 four times a day gives a total daily dose of 3900mg acetaminophen and 1170mg ibuprofen.

The primary objective of the study is to compare time-adjusted SPID of the VAS pain intensity scores up to 48 hours after the first dose of study medication among the four study groups.

Secondary objectives are:

To compare the time to onset of pain relief after the first dose of study drug defined as (i) perceptible and (ii) meaningful pain relief among the four study groups using the two stopwatch method.

To compare the maximum VAS pain scores up to 48 hours after the first dose of study medication among the four study groups.

To compare the response rates (response rate to be defined as the percentage of participants who reduce their pain intensity scores by at least 50% compared with the baseline VAS measure) among the four study groups.

To compare the time to peak reduction in VAS pain intensity scores following the first dose of study medication among the four study groups.

To compare the time to requirement for rescue medication among the four study groups.

To compare the percentage of participants who use rescue medication among the four study groups.

To compare the amount of rescue medication used (defined as number of tablets) among the four study groups.

To compare the categorical global pain rating among the four study groups.

Safety:

To compare adverse event rates for the 48-hour study period and up to Day 30 among the four treatment groups.

To compare the incidence of known specific NSAID and paracetamol side effects (e.g. GI ulceration or bleeding, indigestion/stomach pain, post-operative bleeding, bronchospasm, skin rashes, water retention, renal failure, thromboembolic events and evidence of clinical hepatitis) during the 48-hour study period and up to Day 30 among the four study groups.

Planned hospital admissions and/or surgical operations for an illness or disease which existed before the study drug was given or the participant was randomized in the study will not be considered adverse events.

Arms: arm 1: Acetaminophen 325mg + ibuprofen 97.5mg per tablet, two tablets every 6 hours, orally arm 2: Acetaminophen 325mg per tablet (standard dose acetaminophen), two tablets every 6 hours, orally arm 3: Ibuprofen 97.5mg per tablet (i.e. low dose ibuprofen), two tablets every 6 hours, orally arm 4: Placebo tablets, every 6 hours, orally
Interventions: intervention 1: Maxigesic 325 intervention 2: Acetaminophen intervention 3: Ibuprofen intervention 4: Placebo
Intervention descriptions: intervention 1: Maxigesic USA (acetaminophen 325 mg + ibuprofen 97.5mg), three tablets four times a day with food for 48 hours intervention 2: Acetaminophen 325 mg, 3 tablets four times a day, with food for 48 hours intervention 3: Ibuprofen 97.5mg, three tablets four times a day, with food for 48 hours. intervention 4: placebo, three tablets four times a day, with food for 48 hours

Protocol documents: