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Generated: December 19, 2018

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CLINICAL TRIALS PROFILE FOR CATAFLAM

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Clinical Trials for Cataflam

Trial ID Title Status Sponsor Phase Summary
NCT00276419 Treatment of Breast Pain Using A Medication (Diclofenac) Applied to the Skin Terminated Mayo Clinic Phase 2/Phase 3 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.
NCT00474136 Study to Compare the Pharmacokinetics of IV Diclofenac Sodium (2 Doses)Versus Oral Diclofenac Potassium Completed Javelin Pharmaceuticals Phase 1 The purpose of this study is to assess the pharmacokinetic parameters of intravenous diclofenac sodium (DIC075V) 18.75 mg and 37.5 mg following single- and multiple-dose administration, as compared to oral diclofenac potassium (Cataflam® 50 mg), the approved reference product.
NCT00548678 Platelet Function and Safety After IV and Oral Diclofenac, IV Ketorolac and Oral Aspirin in Adult Volunteers Completed Javelin Pharmaceuticals Phase 1 This study will assess platelet function and safety in healthy male volunteers following doses of intravenous diclofenac compared to oral diclofenac (Cataflam), intravenous ketorolac and oral aspirin.
NCT01797575 N-Acetyl Cysteine and Aspirin as an Adjunctive Treatment for Bipolar Disorder Recruiting Stanley Medical Research Institute Phase 2 We propose to conduct a double-blind placebo-controlled trial with a widely available and prototypical non-steroidal anti-inflammatory agent, aspirin, and an antioxidant agent, NAC, involving symptomatic Bipolar Disorder type I and II patients having a depressive or mixed episode currently. This will be the first controlled study to test the hypothesis that aspirin and NAC, by themselves or in combination, will be beneficial in treating depression in bipolar disorder patients and in promoting mood stabilization. Our study has the following Aims: Aim I - Examine efficacy of aspirin in treating depression in bipolar patients in a double-blind placebo-controlled add-on design; Aim II - Examine efficacy of NAC in treating depression in bipolar patients in a double-blind placebo-controlled add-on design; Aim III - Examine efficacy of combined treatment with aspirin and NAC looking for synergistic, potentiating effects; Aim IV - Examine the role of markers of neuroinflammation, as possible mediators or modulators in therapeutic response in the treatment of depression in patients with Bipolar Disorder.
NCT01797575 N-Acetyl Cysteine and Aspirin as an Adjunctive Treatment for Bipolar Disorder Recruiting The University of Texas Health Science Center, Houston Phase 2 We propose to conduct a double-blind placebo-controlled trial with a widely available and prototypical non-steroidal anti-inflammatory agent, aspirin, and an antioxidant agent, NAC, involving symptomatic Bipolar Disorder type I and II patients having a depressive or mixed episode currently. This will be the first controlled study to test the hypothesis that aspirin and NAC, by themselves or in combination, will be beneficial in treating depression in bipolar disorder patients and in promoting mood stabilization. Our study has the following Aims: Aim I - Examine efficacy of aspirin in treating depression in bipolar patients in a double-blind placebo-controlled add-on design; Aim II - Examine efficacy of NAC in treating depression in bipolar patients in a double-blind placebo-controlled add-on design; Aim III - Examine efficacy of combined treatment with aspirin and NAC looking for synergistic, potentiating effects; Aim IV - Examine the role of markers of neuroinflammation, as possible mediators or modulators in therapeutic response in the treatment of depression in patients with Bipolar Disorder.
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 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Cataflam

Condition Name

Condition Name for Cataflam
Intervention Trials
Healthy 2
Non-cyclical Mastalgia 1
Ventricular Repolarization 1
Surgical Scar-Related Breast Pain 1
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Condition MeSH

Condition MeSH for Cataflam
Intervention Trials
Mastodynia 1
Pulpitis 1
Poisoning 1
Periodontitis 1
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Clinical Trial Locations for Cataflam

Trials by Country

Trials by Country for Cataflam
Location Trials
United States 5
Egypt 1
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Trials by US State

Trials by US State for Cataflam
Location Trials
Maryland 1
Minnesota 1
North Dakota 1
Texas 1
Florida 1
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Clinical Trial Progress for Cataflam

Clinical Trial Phase

Clinical Trial Phase for Cataflam
Clinical Trial Phase Trials
Phase 2/Phase 3 2
Phase 2 2
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for Cataflam
Clinical Trial Phase Trials
Completed 5
Recruiting 1
Terminated 1
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Clinical Trial Sponsors for Cataflam

Sponsor Name

Sponsor Name for Cataflam
Sponsor Trials
Javelin Pharmaceuticals 2
Cairo University 2
Mayo Clinic 1
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Sponsor Type

Sponsor Type for Cataflam
Sponsor Trials
Other 7
Industry 3
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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Merck
Teva
Harvard Business School
Argus Health
Johnson and Johnson
Federal Trade Commission
Daiichi Sankyo
Baxter

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