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Perinorm injection im or iv, and intravenous infusion of 4 mg/h clodronate (Sigma Corp.) as a vehicle. second phase of an open-label trial is planned. In the open label analysis, participants with mild- to moderate-pain were excluded if there was a history of significant medical illness, liver, thyroid, heart/lung or renal disease, a history of bleeding disorder.
The study was conducted under an Investigational New Drug Application issued to Biogen Idec.
A separate phase 2B (N=13) study, called the AHRP II/3 study (AHRP2, AHRP3, 3b), includes patients with severe to osteoarthritic disorders who had a maximum pain score in the low-medium range and was not responding to clodronate and/or hydralazine. In this phase, clodronate is added as monotherapy or adjunct therapy, well as hydralazine. Phase 2B analysis was done on patients using IV hydralazine.
Biotia Therapeutics filed for a patent on clodronate April 21, 2012 and received the first patent in May 2014. February 2016, the U.S. Patent and Trademark Office added three additional patents to the patent portfolio, for anti-inflammatory, anti-obesity and anti-inflammatory treatment.
About the FDA-approved Phase 3 RCTs
AHRP Phase 3 studies (clodronate and hydralazine in patients with mild to moderate osteoarthritic disorders, hydralazine in patients with severe osteoarthritic disorders and clodronate in patients with moderate osteoarthritic disorders) are ongoing, with no study data from the first AHRP study completed at the completion and date of publication as Feb 2016. Phase 3 enrollment in the U.S. is ongoing. Additional AHRP studies are planned to evaluate the safety and efficacy data.
Clodronate and Hydralazine in Patients with Mild-To-Moderate Osteoarthritic Disorders
Clodronate was assessed in a double-blind, parallel-group, placebo-controlled study in patients with a maximum pain score ≤ 30 from a of 15 to 60 for the use of IM administration as adjunctive therapy a single IV bolus dose of 20 mg clodronate or hydralazine. Patients were considered Buy viagra in brisbane australia in remission if they achieved at least a 75% reduction in their pain score. Patients had received clodronate for at least three months prior to the study, whereas patients in other three arms received either placebo OR hydralazine (2.55 mg/h) and then either clodronate OR hydralazine placebo, and then either placebo or hydralazine. The study was designed to compare the effect of IM administration vs. IV administration. All AHRP study sites and primary outcomes in the study have passed final analysis stage. Primary outcome measures include pain intensity, tolerability, analgesic drug effects (such as the proportion of dose attributable to drug versus placebo) and overall analgesic effect (such as drug vs placebo on pain intensity). The primary analysis, which included all patient-level primary outcome measures, was analyzed using logistic regression analysis, with clodronate as the exposure and pain level as the outcome. A secondary analysis of the was that proportion trial completion attributable to study drug, with the dose of clodronate as exposure and pain level the end point. Patients randomized in the placebo arm completed study in approximately 2 months, whereas the hydralazine arm is ongoing with a 4-month period of follow up. Pain intensity was assessed by a visual analog scales.
Clodronate administration vs IV was not randomized. Patient characteristics (see table A1) were similar regardless of which route administration was used, with differences favoring clodronate administration in the dose of Is prozac available in the uk clodronate used and in the presence of renal dysfunction, prior opioid use or an adverse event involving clodronate. The mean age in this study (mean±SD) was 70±14 years. The median dose of clodronate in all treated patients was 10 mg/day. In this study, clodronate was not associated with adverse events in patients receiving 20 mg/day and in those receiving 20 mg for three months compared with placebo or hydralazine.
Clodronate was well-tolerated in the AHRP I/3 study for an Disulfiram $1.66 - pills Per pill IV injection dose of 20 mg clodronate and in randomized patients AHRP II/3 where hydralazine and placebo were studied as adjuncts.
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