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Trial record 7 of 179 for:    Migraine AND migraine with or without aura

Pharmacokinetics & Safety of Cambia® in Migraine With or Without Aura in 12-17 Year Olds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02287376
Recruitment Status : Completed
First Posted : November 10, 2014
Results First Posted : July 25, 2017
Last Update Posted : July 25, 2017
Sponsor:
Information provided by (Responsible Party):
Depomed

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Migraine
Intervention Drug: Diclofenac Potassium for Oral Solution
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cambia®
Hide Arm/Group Description Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Period Title: Overall Study
Started 25
Completed 25
Not Completed 0
Arm/Group Title Cambia®
Hide Arm/Group Description Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
15.5  (1.66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
21
  84.0%
Male
4
  16.0%
1.Primary Outcome
Title Pharmacokinetics Outcome (1 of 6)
Hide Description • Cmax: maximum concentration (ng/mL)
Time Frame 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.
Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cmax (ng/mL) Number Analyzed 25 participants
1411.96  (846.208)
pre-dose concentrations (ng/mL) Number Analyzed 25 participants
0.00  (0.000)
5 min post-dose concentrations (ng/mL) Number Analyzed 25 participants
649.78  (1008.783)
10 min post-dose concentrations (ng/mL) Number Analyzed 25 participants
1123.88  (881.619)
15 min post-dose concentrations (ng/mL) Number Analyzed 25 participants
1247.72  (824.194)
20 min post-dose concentrations (ng/mL) Number Analyzed 25 participants
1084.52  (575.825)
30 min post-dose concentrations (ng/mL) Number Analyzed 25 participants
855.92  (469.835)
40 min post-dose concentrations (ng/mL) Number Analyzed 25 participants
629.96  (295.361)
60 min post-dose concentrations (ng/mL) Number Analyzed 25 participants
535.44  (295.222)
2 hrs post-dose concentrations (ng/mL) Number Analyzed 25 participants
164.25  (107.706)
4 hrs post-dose concentrations (ng/mL) Number Analyzed 24 participants
40.20  (25.285)
6 hrs post-dose concentrations (ng/mL) Number Analyzed 24 participants
14.26  (7.507)
2.Primary Outcome
Title Pharmacokinetics Outcome (2 of 6)
Hide Description • tmax: time to maximum concentration (min)
Time Frame 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.
Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: min
18.00  (11.551)
3.Primary Outcome
Title Pharmacokinetics Outcome (3 of 6)
Hide Description • λz: elimination rate constant associated with the terminal (log linear) portion of the curve (1/min)
Time Frame 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.
Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: 1/min
0.01  (0.002)
4.Primary Outcome
Title Pharmacokinetics Outcome (4 of 6)
Hide Description • t1/2: terminal elimination half-life (min)
Time Frame 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.
Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: min
66.79  (9.193)
5.Primary Outcome
Title Pharmacokinetics Outcome (5 of 6)
Hide Description • AUC 0-t: area under the concentration-time curve from time 0 to last time point (t) where diclofenac could be measured (min*ng/mL)
Time Frame 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.
Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: min*ng/mL
82920.03  (25327.634)
6.Primary Outcome
Title Pharmacokinetics Outcome (6 of 6)
Hide Description • AUC 0-∞: area under the concentration-time curve from time 0 to infinity (∞) (min*ng/mL)
Time Frame 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.
Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: min*ng/mL
84388.75  (25993.623)
7.Secondary Outcome
Title Safety Outcome (1 of 7)
Hide Description • Treatment emergent AEs (TEAEs)
Time Frame 3 months (time of first dose of study medication taken to 30 days after the last dose of study medication taken)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population included all subjects who have received at least 1 dose of study drug.
Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
10
  40.0%
8.Secondary Outcome
Title Safety Outcome (2 of 7)
Hide Description • Serious adverse events (SAEs)
Time Frame 3 months (signed informed consent/assent to 30 days post Day 90 or last dose of study medication taken)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population included all subjects who have received at least 1 dose of study drug.
Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
1
   4.0%
9.Secondary Outcome
Title Safety Outcome (3 of 7)
Hide Description • Withdrawals due to AEs
Time Frame 3 months (signed informed consent/assent to 30 days after the last dose of study medication taken)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population included all subjects who have received at least 1 dose of study drug.
Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
10.Secondary Outcome
Title Safety Outcome (4 of 7)
Hide Description • Deaths
Time Frame 3 months (signed informed consent/assent to 30 days post Day 90 or last dose of study medication taken)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population included all subjects who have received at least 1 dose of study drug.
Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
11.Secondary Outcome
Title Safety Outcome (5.1 of 7)
Hide Description • Changes in vital sign measurements: Temperature (degrees C).
Time Frame 3 months (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: degrees C
Baseline (degrees C) 36.52  (0.569)
Final Visit (degrees C) 36.72  (0.499)
Change from Baseline to Final Visit (degrees C) 0.20  (0.491)
12.Secondary Outcome
Title Safety Outcome (5.2 of 7)
Hide Description • Changes in vital sign measurements: Heart Rate (beats/min).
Time Frame 3 months (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: beats/min
Baseline (beats/min) 74.6  (12.41)
Final Visit (beats/min) 74.7  (9.23)
Change from Baseline to Final Visit (beats/min) 0.2  (10.95)
13.Secondary Outcome
Title Safety Outcome (5.3 of 7)
Hide Description • Changes in vital sign measurements: Respiratory Rate (breaths/min).
Time Frame 3 months (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: breaths/min
Baseline (breaths/min) 15.4  (1.23)
Final Visit (breaths/min) 15.6  (0.82)
Change from Baseline to Final Visit (breaths/min) 0.1  (1.42)
14.Secondary Outcome
Title Safety Outcome (5.4 of 7)
Hide Description • Changes in vital sign measurements: Systolic Blood Pressure (mmHg).
Time Frame 3 months (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: mm Hg
Baseline (mm Hg) 112.7  (11.71)
Final Visit (mm Hg) 109.6  (9.83)
Change from Baseline to Final Visit (mm Hg) -3.1  (14.27)
15.Secondary Outcome
Title Safety Outcome (5.5 of 7)
Hide Description • Changes in vital sign measurements: Diastolic Blood Pressure (mmHg).
Time Frame 3 months (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: mm Hg
Baseline (mm Hg) 68.8  (8.78)
Final Visit (mm Hg) 67.1  (7.07)
Change from Baseline to Final Visit (mm Hg) -1.7  (9.62)
16.Secondary Outcome
Title Safety Outcome (6.1 of 7)
Hide Description • Changes in clinical laboratory results: Hematology - Hematocrit (L/L).
Time Frame 3 months (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: L/L
Baseline (L/L) 0.388  (0.0329)
Final Visit (L/L) 0.408  (0.0344)
Change from Baseline to Final Visit (L/L) 0.020  (0.0190)
17.Secondary Outcome
Title Safety Outcome (6.2 of 7)
Hide Description • Changes in clinical laboratory results: Hematology - Hemoglobin (g/L).
Time Frame 3 months (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: g/L
Baseline (g/L) 128.000  (11.4419)
Final Visit (g/L) 132.720  (11.6638)
Change from Baseline to Final Visit (g/L) 4.720  (5.4430)
18.Secondary Outcome
Title Safety Outcome (6.3 of 7)
Hide Description • Changes in clinical laboratory results: Hematology - Platelet Count (Cells * 10^9/L).
Time Frame 3 months (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Cells * 10^9/L
Baseline (Cells * 10^9/L) 233.640  (43.4855)
Final Visit (Cells * 10^9/L) 244.960  (47.0049)
Change from Baseline to Final Visit (Cells*10^9/L) 11.320  (42.3642)
19.Secondary Outcome
Title Safety Outcome (6.4 of 7)
Hide Description • Changes in clinical laboratory results: Hematology - White Blood Cells (Cells * 10^9/L).
Time Frame 3 months (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Cells * 10^9/L
Baseline (Cells * 10^9/L) 6.512  (1.9935)
Final Visit (Cells * 10^9/L) 6.262  (1.4957)
Change from Baseline to Final Visit (Cells*10^9/L) -0.249  (2.0634)
20.Secondary Outcome
Title Safety Outcome (6.5 of 7)
Hide Description • Changes in clinical laboratory results: Hematology - Basophils (%).
Time Frame 3 months (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: % Basophils
Baseline (% Basophils) 0.324  (0.3829)
Final Visit (% Basophils) 0.350  (0.3766)
Change from Baseline to Final Visit (% Basophils) 0.026  (0.5190)
21.Secondary Outcome
Title Safety Outcome (6.6 of 7)
Hide Description • Changes in clinical laboratory results: Hematology - Eosinophils (%).
Time Frame 3 months (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: % Eosinophils
Baseline (% Eosinophils) 2.730  (2.0728)
Final Visit (% Eosinophils) 2.036  (1.6519)
Change from Baseline to Final Visit(% Eosinophils) -0.694  (1.7186)
22.Secondary Outcome
Title Safety Outcome (6.7 of 7)
Hide Description • Changes in clinical laboratory results: Hematology - Neutrophils (%).
Time Frame 3 months (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: % Neutrophils
Baseline (% Neutrophils) 54.530  (9.7221)
Final Visit (% Neutrophils) 57.932  (8.4095)
Change from Baseline to Final Visit(% Neutrophils) 3.402  (10.1083)
23.Secondary Outcome
Title Safety Outcome (6.8 of 7)
Hide Description • Changes in clinical laboratory results: Hematology - Lymphocytes (%).
Time Frame 3 months (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: % Lymphocytes
Baseline (% Lymphocytes) 36.260  (8.9981)
Final Visit (% Lymphocytes) 33.745  (7.5260)
Change from Baseline to Final Visit(% Lymphocytes) -2.515  (9.1165)
24.Secondary Outcome
Title Safety Outcome (6.9 of 7)
Hide Description • Changes in clinical laboratory results: Hematology - Monocytes (%).
Time Frame 3 months (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: % Monocytes
Baseline (% Monocytes) 6.030  (1.8765)
Final Visit (% Monocytes) 5.847  (1.7170)
Change from Baseline to Final Visit (% Monocytes) -0.183  (1.7852)
25.Secondary Outcome
Title Safety Outcome (6.10 of 7)
Hide Description • Changes in clinical laboratory results: Chemistry - Albumin (g/L).
Time Frame 3 months (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: g/L
Baseline (g/L) 43.800  (4.0415)
Final Visit (g/L) 47.200  (4.4441)
Change from Baseline to Final Visit (g/L) 3.400  (3.0277)
26.Secondary Outcome
Title Safety Outcome (6.11 of 7)
Hide Description • Changes in clinical laboratory results: Chemistry - Alkaline Phosphatase (U/L).
Time Frame 3 months (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: U/L
Baseline (U/L) 98.960  (85.0022)
Final Visit (U/L) 103.760  (89.5378)
Change from Baseline to Final Visit (U/L) 4.800  (11.4054)
27.Secondary Outcome
Title Safety Outcome (6.12 of 7)
Hide Description • Changes in clinical laboratory results: Chemistry - ALT (SGPT) (U/L).
Time Frame 3 months (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: U/L
Baseline (U/L) 12.680  (5.7134)
Final Visit (U/L) 13.080  (5.1553)
Change from Baseline to Final Visit (U/L) 0.400  (2.0817)
28.Secondary Outcome
Title Safety Outcome (6.13 of 7)
Hide Description • Changes in clinical laboratory results: Chemistry - AST (SGOT) (U/L).
Time Frame 3 months (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: U/L
Baseline (U/L) 17.240  (4.5760)
Final Visit (U/L) 18.040  (4.6947)
Change from Baseline to Final Visit (U/L) 0.800  (2.6615)
29.Secondary Outcome
Title Safety Outcome (6.14 of 7)
Hide Description • Changes in clinical laboratory results: Chemistry - Bicarbonate (CO2) (mmol/L).
Time Frame 3 months (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline (mmol/L) 23.400  (1.8028)
Final Visit (mmol/L) 23.920  (2.1970)
Change from Baseline to Final Visit (mmol/L) 0.520  (2.7099)
30.Secondary Outcome
Title Safety Outcome (6.15 of 7)
Hide Description • Changes in clinical laboratory results: Chemistry - Bilirubin Total (umol/L).
Time Frame 3 months (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: umol/L
Baseline (umol/L) 9.029  (4.1454)
Final Visit (umol/L) 10.192  (5.5311)
Change from Baseline to Final Visit (umol/L) 1.163  (3.9107)
31.Secondary Outcome
Title Safety Outcome (6.16 of 7)
Hide Description • Changes in clinical laboratory results: Chemistry - BUN (Urea) (mmol/L).
Time Frame 3 months (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline (mmol/L) 4.512  (1.0858)
Final Visit (mmol/L) 4.594  (1.2965)
Change from Baseline to Final Visit (mmol/L) 0.081  (1.0515)
32.Secondary Outcome
Title Safety Outcome (6.17 of 7)
Hide Description • Changes in clinical laboratory results: Chemistry - Chloride (mmol/L).
Time Frame 3 months (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline (mmol/L) 105.480  (1.9604)
Final Visit (mmol/L) 104.880  (2.7435)
Change from Baseline to Final Visit (mmol/L) -0.600  (2.1602)
33.Secondary Outcome
Title Safety Outcome (6.18 of 7)
Hide Description • Changes in clinical laboratory results: Chemistry - Creatinine (umol/L).
Time Frame 3 months (signed informed consent/assent to the final visit)
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Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
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Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: umol/L
Baseline (umol/L) 66.760  (11.2603)
Final Visit (umol/L) 67.467  (10.7228)
Change from Baseline to Final Visit (umol/L) 0.707  (8.1866)
34.Secondary Outcome
Title Safety Outcome (6.19 of 7)
Hide Description • Changes in clinical laboratory results: Chemistry - Glucose (mmol/L).
Time Frame 3 months (signed informed consent/assent to the final visit)
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Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline (mmol/L) 4.758  (0.6037)
Final Visit (mmol/L) 4.483  (0.8590)
Change from Baseline to Final Visit (mmol/L) -0.275  (0.9215)
35.Secondary Outcome
Title Safety Outcome (6.20 of 7)
Hide Description • Changes in clinical laboratory results: Chemistry - LDH (U/L).
Time Frame 3 months (signed informed consent/assent to the final visit)
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Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: U/L
Baseline (U/L) Number Analyzed 17 participants
157.882  (59.0824)
Final Visit (U/L) Number Analyzed 24 participants
159.708  (41.5425)
Change from Baseline to Final Visit (U/L) Number Analyzed 17 participants
-0.882  (74.6064)
36.Secondary Outcome
Title Safety Outcome (6.21 of 7)
Hide Description • Changes in clinical laboratory results: Chemistry - Potassium (mmol/L).
Time Frame 3 months (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline (mmol/L) 3.964  (0.2215)
Final Visit (mmol/L) 4.060  (0.2784)
Change from Baseline to Final Visit (mmol/L) 0.096  (0.3007)
37.Secondary Outcome
Title Safety Outcome (6.22 of 7)
Hide Description • Changes in clinical laboratory results: Chemistry - Sodium (mmol/L).
Time Frame 3 months (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline (mmol/L) 138.640  (1.0360)
Final Visit (mmol/L) 138.840  (1.5188)
Change from Baseline to Final Visit (mmol/L) 0.200  (1.6833)
38.Secondary Outcome
Title Safety Outcome (6.23 of 7)
Hide Description • Changes in clinical laboratory results: Urinalysis - pH.
Time Frame 3 months (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: pH
Baseline (pH) 6.220  (0.7511)
Final Visit (pH) 6.300  (0.7773)
Change from Baseline to Final Visit (pH) 0.080  (0.8977)
39.Secondary Outcome
Title Safety Outcome (6.24 of 7)
Hide Description • Changes in clinical laboratory results: Urinalysis - Specific Gravity.
Time Frame 3 months (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Specific Gravity
Baseline (Specific Gravity) 1.020  (0.0085)
Final Visit (Specific Gravity) 1.022  (0.0060)
Change from Baseline to Final Visit (Spec.Gravity) 0.002  (0.0081)
40.Secondary Outcome
Title Safety Outcome (7 of 7)
Hide Description • Physical examination findings including abnormal clinically significant findings
Time Frame 3 months (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

The Safety population included all subjects who have received at least 1 dose of study drug.

The data presented is a clinically significant change from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.

Arm/Group Title Cambia®
Hide Arm/Group Description:
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
1
   4.0%
Time Frame 3 months (signed informed consent/assent to 30 days post Day 90 or last dose of study medication taken)
Adverse Event Reporting Description The Safety population included all subjects who have received at least 1 dose of study drug.
 
Arm/Group Title Cambia®
Hide Arm/Group Description Diclofenac Potassium for Oral Solution (NSAID), 50 mg
All-Cause Mortality
Cambia®
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cambia®
Affected / at Risk (%)
Total   1/25 (4.00%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal Pain  1/25 (4.00%) 
Nervous system disorders   
Migraine  1/25 (4.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cambia®
Affected / at Risk (%)
Total   4/25 (16.00%) 
Ear and labyrinth disorders   
Motion Sickness  2/25 (8.00%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  2/25 (8.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The PI agrees that sponsor shall have the right to the first publication of the study results which is intended to be a joint, multi-center publication. Following the first publication, the PI may publish study data or results, provided however PI submits the proposed publication to sponsor for review at least 60 days prior to the date of the proposed publication. Sponsor may remove any information that is considered confidential and / or proprietary other than study data.
Results Point of Contact
Name/Title: Clinical Operations
Organization: Depomed
Phone: 510-744-8000
Responsible Party: Depomed
ClinicalTrials.gov Identifier: NCT02287376     History of Changes
Other Study ID Numbers: 81-0076
First Submitted: November 5, 2014
First Posted: November 10, 2014
Results First Submitted: January 24, 2017
Results First Posted: July 25, 2017
Last Update Posted: July 25, 2017