CLINICAL TRIALS PROFILE FOR ZIPSOR
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All Clinical Trials for ZIPSOR
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00276419 ↗ | Treatment of Breast Pain Using A Medication (Diclofenac) Applied to the Skin | Terminated | Mayo Clinic | Phase 2/Phase 3 | 2005-06-01 | The study was a randomized, double-blinded, crossover trial of topical diclofenac and placebo (10 weeks of each) for the treatment of noncyclic breast pain. |
| NCT01812538 ↗ | A Randomized, Single-Dose, Comparative, Positive and Placebo Controlled, Four-Way, Four Period, Cross-Over Study to Evaluate the Effect of DIC075V on QTc Intervals in Healthy Subjects | Completed | Hospira, Inc. | Phase 1 | 2009-05-01 | This study is conducted to evaluate the effectiveness of DIC075V on ventricular repolarization in healthy subjects compared to placebo after a single dose of DIC075V administered intravenously (IV) and to evaluate ECG assay sensitivity by evaluating the baseline-adjusted effect of a single oral (PO) moxifloxacin 400 mg dose on ventricular repolarization in healthy subjects compared to placebo. Other secondary objectives are as follows: - To evaluate the effect of DIC075V on ventricular repolarization in healthy subjects compared to placebo at the Tmax of diclofenac and hydroxypropyl-β-cyclodextrin (HPβCD). - To determine if there is a pharmacokinetic/pharmacodynamic (PK/PD) relationship between the duration of the QTc intervals and diclofenac and HPβCD plasma concentrations. - Obtain additional pharmacokinetic (PK) information on diclofenac and HPβCD in healthy subjects. - Provide additional safety information. |
| NCT01812538 ↗ | A Randomized, Single-Dose, Comparative, Positive and Placebo Controlled, Four-Way, Four Period, Cross-Over Study to Evaluate the Effect of DIC075V on QTc Intervals in Healthy Subjects | Completed | Hospira, now a wholly owned subsidiary of Pfizer | Phase 1 | 2009-05-01 | This study is conducted to evaluate the effectiveness of DIC075V on ventricular repolarization in healthy subjects compared to placebo after a single dose of DIC075V administered intravenously (IV) and to evaluate ECG assay sensitivity by evaluating the baseline-adjusted effect of a single oral (PO) moxifloxacin 400 mg dose on ventricular repolarization in healthy subjects compared to placebo. Other secondary objectives are as follows: - To evaluate the effect of DIC075V on ventricular repolarization in healthy subjects compared to placebo at the Tmax of diclofenac and hydroxypropyl-β-cyclodextrin (HPβCD). - To determine if there is a pharmacokinetic/pharmacodynamic (PK/PD) relationship between the duration of the QTc intervals and diclofenac and HPβCD plasma concentrations. - Obtain additional pharmacokinetic (PK) information on diclofenac and HPβCD in healthy subjects. - Provide additional safety information. |
| NCT01982539 ↗ | Safety and Tolerability of Zipsor® in Pediatric Subjects (Ages 12-17 Years) With Mild to Moderate Acute | Completed | Depomed | Phase 4 | 2013-11-01 | As part of the PREA(Pediatric Research Equity Act) commitment, the objective of the study is to confirm safety and tolerability of 25 mg of Zipsor® in clinical pediatric subjects. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for ZIPSOR
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Clinical Trial Sponsors for ZIPSOR
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