Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0030193 (pain)
 261,466 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

5% Amlexanox oral paste (Aphthasol) was studied in four vehicle-controlled, randomized, double-blind, parallel group, multicenter, clinical studies involving 1335 subjects who had 1 to 3 aphthous ulcers less than 48 hours old at enrollment. Subjects applied study pastes directly to ulcers four times a day until ulcers healed or for the duration of the study, whichever occurred first. Ulcer size was measured by the investigator and pain was evaluated by the subject; the primary determinant of efficacy was the percentage of subjects with complete healing of ulcers and complete resolution of ulcer pain. The vehicle had marginal beneficial effects as would be expected from a covering material, but statistical significance over no treatment was inconsistent. However, these studies, both individually and collectively, clearly demonstrated in a highly significant and consistent manner that in comparison to both Vehicle and No Treatment 5% Amlexanox oral paste accelerates the resolution of pain and healing of aphthous ulcers.
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PMID:5% amlexanox oral paste, a new treatment for recurrent minor aphthous ulcers: I. Clinical demonstration of acceleration of healing and resolution of pain. 911 54

Five percent Amlexanox oral paste is a novel treatment for aphthous ulcers. In 3 controlled clinical studies that evaluated 1,124 immunocompetent patients with mild to moderate aphthous ulcers, 5% Amlexanox oral paste (Aphthasol) was shown to accelerate healing of these ulcers. Treatment with Aphthasol reduced the median time to ulcer healing and to complete pain resolution in a statistically significant manner. This was true both when treatment with 5% Amlexanox oral paste was compared to treatment with a vehicle and when treatment with the Amlexanox paste was compared to no treatment. Study results after 3 days comparing treatment with the paste and no treatment indicated complete healing of ulcers for 21% and 8% of patients, respectively. Complete resolution of pain after 3 days was reported for 44% and 20% of patients, respectively.
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PMID:Amlexanox oral paste: a novel treatment that accelerates the healing of aphthous ulcers. 953 45

Recurrent aphthous ulcer (RAU) is the most prevalent oral mucosal disease in humans, estimated to affect between 5% and 50% of the general population. The minor manifestation of the condition is the most common and is characterised by small, shallow, round or oval lesions that are surrounded by a raised erythematous halo and are covered by a grey-white pseudomembrane. Appropriate management of patients with this condition is largely symptomatic and should focus on reducing ulcer duration, relieving pain and reducing or preventing ulcer recurrence. Amlexanox is a novel anti-inflammatory and anti-allergic agent that has been evaluated for the treatment of RAU in a series of robust clinical trials. After a 100mg dose of 5% amlexanox topical paste, applied directly to the lesion, the maximum serum concentration of the drug was 120 ng/mL, which was achieved 2.4 hours after application. Steady-state concentrations were achieved within 1 week of starting four times daily dosing and there was no evidence of accumulation. In terms of efficacy, application of 5% amlexanox topical paste was shown to consistently and significantly accelerate complete ulcer healing and the time to resolution of pain across four large efficacy studies. Significantly more patients had completely healed ulcers from day 3 (compared with no treatment) and day 4 (compared with vehicle). Healing was mirrored by an improvement in pain: significantly more patients had complete resolution of pain from day 2 (compared with no treatment) and day 3 (compared with vehicle). Overall, amlexanox was well tolerated, with a low frequency of adverse effects. In the oral application studies, adverse effects that were considered by investigators to be potentially related to the study treatment occurred in 2.4% and 2.1% of 5% amlexanox and vehicle recipients, respectively. These effects were mainly local and were all classed as mild to moderate in severity, with the exception of one case of severe stinging in the vehicle treatment group. Furthermore, the incidence of dermal irritation and sensitisation was very low with amlexanox. These findings suggest that 5% amlexanox topical paste is a useful and well tolerated therapeutic option for the treatment of RAU.
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PMID:Amlexanox for the treatment of recurrent aphthous ulcers. 1753

Amlexanox appears to be most effective overall. Amlexanox 5% paste reduces ulcer size, pain duration, and healing time.
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PMID:Clinical inquiry. What is the most effective way to treat recurrent canker sores? 2197 91