Auranofin in Decreasing Pain in Patients With Paclitaxel-Induced Pain Syndrome

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT02063698
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 32.7
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

This randomized pilot clinical trial studies whether auranofin will relieve pain following paclitaxel in patients who have previously experienced paclitaxel-induced pain. Auranofin is a drug given by mouth to treat other diseases such as rheumatoid arthritis, and is being studied to see if it will decrease pain following paclitaxel.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: auranofin; Other: placebo; Other: questionnaire administration	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

1. Determine whether one dose of auranofin given the day following administration of paclitaxel decreases pain as assessed by daily completion of the Modified Brief Pain Inventory scale for seven days.

SECONDARY OBJECTIVES:

1. Assess whether auranofin is well tolerated in this setting.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive auranofin orally (PO) on day 2.

ARM II: Patients receive placebo PO on day 2.

After completion of study treatment, patients are followed up at 21-28 days.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: A Pilot Randomized, Placebo-Controlled Study to Test Auranofin (Ridaura®) to Control the Paclitaxel-Induced Pain Syndrome (PIAPS)
• Actual Study Start Date: Feb 19, 2014
• Actual Primary Completion Date: Nov 11, 2015
• Actual Study Completion Date: Nov 11, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I (auranofin) Patients receive auranofin PO on day 2.	Drug: auranofin; Given PO; Other Names: Ridaura ; Other: questionnaire administration; Ancillary studies
Placebo Comparator: Arm II (placebo) Patients receive placebo PO on day 2.	Other: placebo; Given PO; Other Names: PLCB ; Other: questionnaire administration; Ancillary studies

Outcome Measures

Primary Outcome Measures

1. Count/Percentage of Patients Who Report Having Experienced the Paclitaxel-induced Pain Syndrome (PIAPS) for One Week After Paclitaxel After Enrollment to the Current Trial, Assessed by the Modified Brief Pain Inventory Scale (BPI) [Up to 28 days]

   The primary endpoint is the per arm count/percentage of patients who report having experienced the PIAPS for one week after paclitaxel after enrollment to the current trial. Pain was assessed on the question 'Please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours'. The count of participants who report having experienced the PIAPS for one week after paclitaxel after enrollment to the current trial circling 'less than 4' and 'greater than or equal to 4' for each day between day 2 to day 8 are reported below. Modified Brief Pain Inventory (BPI) ranges from 0 to 10, with higher scores corresponding to more /worse pain. Fisher's Exact Test will be used to compare the frequency of patients who experienced PIAPS between the two arms.

2. Area Under the Curve (AUC) Summary of Worst Pain in the Last 24 Hours From Days 2 to 8 [Up to 8 days]

   Area under the curve (AUC) Summary of Worst Pain in the last 24 hours from days 2 to 8. On a scale of 0-100, with 100=Best QOL. Pain was assessed on the question 'Please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours.' Modified Brief Pain Inventory (BPI) ranges from 0 to 10, with higher scores corresponding to more pain. The AUC for this question was then calculated and ranged from 0-100, with higher scores corresponding to less/improved pain. The Equal Variance T-test will be used to compare the average AUC for worst pain between the two arms.

Secondary Outcome Measures

1. Normalized AUC for BPI Average Pain From the Modified BPI in the Last 24 Hours From Days 2 to 8 [Up to 28 days]

   Normalized AUC for BPI Average pain from the modified BPI in the last 24 hours from days 2 to 8. On a scale of 0-100 with 100:Best QOL. Pain was assessed on the question 'Please rate your pain by circling the one number that best describes your pain on the average.' Modified Brief Pain Inventory (BPI) ranges from 0 to 10, with higher scores corresponding to more pain. The AUC for this question was then calculated and ranged from 0-100, with higher scores corresponding to less/improved pain. The Equal Variance T-test will be used to compare the average AUC for worst pain between the two arms.

2. Worst Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4 [Up to 28 days]

   The maximum grade for each type of toxicity will be recorded for each patient. The count of participants with worst adverse events considered at least possibly related to treatment by maximum grade are reported below.

3. Cramp Pain as Measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 5 [Up to 5 days]

   Cramp Pain as measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 5. The PIAPS question 'Please place a check mark (√) by all appropriate words that could be used to describe any pain you have had in the last 24 hours'. The number of participants who completed this question on day 5 were analyzed (those who checked 'cramping' are summarized by the 'Yes' row below and those who did not check 'cramping' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used.

4. Gnawing Pain as Measure by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 8 [Up to 8 days]

   Gnawing Pain as measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 8. The PIAPS question 'Please place a check mark (√) by all appropriate words that could be used to describe any pain you have had in the last 24 hours'. The number of participants who completed this question on day 8 were analyzed (those who checked 'gnawing' are summarized by the 'Yes' row below and those who did not check 'gnawing' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used.

5. Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Upper Arm Pain [Up to 5 days]

   Location of New Pain Patient had in the last 24 hours on day 5 PIAPS Upper arm pain. PIAPS question: "Please indicate where any new pains are/were located by placing a check mark (√) next to the location. Please mark all that apply:" The number of participants who completed this question on day 5 were analyzed (those who checked 'arm, above the elbow' are summarized by the 'Yes' row below and those who did not check 'arm, above the elbow' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used.

6. Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Lower Arm Pain. [Up to 5 days]

   Location of New Pain Patient had in the last 24 hours on day 5 PIAPS Lower arm pain. PIAPS question: "Please indicate where any new pains are/were located by placing a check mark (√) next to the location. Please mark all that apply:" The number of participants who completed this question on day 5 were analyzed (those who checked 'arm, between the elbows and wrists' are summarized by the 'Yes' row below and those who did not check 'arm, between the elbows and wrists' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used.

7. Location of New Pain Patient Had in the Last 24 Hours on Day 6 PIAPS Lower Arm Pain. [Up to 6 days]

   Location of New Pain Patient had in the last 24 hours on day 6 PIAPS Lower arm pain. PIAPS question: "Please indicate where any new pains are/were located by placing a check mark (√) next to the location. Please mark all that apply:" The number of participants who completed this question on day 5 were analyzed (those who checked 'arm, between the elbows and wrists' are summarized by the 'Yes' row below and those who did not check 'arm, between the elbows and wrists' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Absolute neutrophil count (ANC) >= 1500/mm^3

• Platelet count (PLT) >= 100,000/mm^3

• Creatinine =< 2 x upper limit of normal (ULN)

• Either serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) or serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 1.5 x ULN

• Total/direct bilirubin =< 1.5 x ULN

• Alkaline phosphatase =< 1.5 x ULN

• Hemoglobin >= 9 mg/dL

• Negative urine or serum pregnancy test performed =< 7 days prior to registration, for women of childbearing potential only

• Previously experienced paclitaxel induced pain during a current or past paclitaxel treatment that the treating healthcare provider thinks is consistent with the paclitaxel-induced acute pain syndrome; note: formal documentation of prior pain is not required

• Scheduled to receive paclitaxel at a dose >= 70 mg/m^2 =< 14 days from randomization

• Ability to complete the questionnaires or to do so with assistance

Exclusion Criteria:

• Pregnant women

• Nursing women

• Any woman of childbearing potential or male partner of a woman of childbearing potential unwilling to employ acceptable contraception throughout the study and for at least 30 days after the last dose of the study drug

• History of gold-induced disorders, including but not limited to, necrotizing enterocolitis, pulmonary fibrosis, exfoliative dermatitis, bone marrow aplasias or other severe hematologic disorders; history of severe allergic or anaphylactic reactions or hypersensitivity to auranofin or other gold compounds

• Currently receiving Dilantin (phenytoin) or auranofin or another gold-containing compound

• Anticipated use of filgrastim (G-CSF) or sargramostim (GM-CSF) within 30 days after receiving auranofin

• Currently receiving immune-modulating therapies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Aminah Jatoi, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02063698
• Other Study ID Numbers: MC1364; NCI-2014-00165; MC1364; P30CA015083
• First Posted: Feb 14, 2014
• Last Update Posted: Apr 23, 2019
• Last Verified: Dec 1, 2018

• Additional relevant MeSH terms: Auranofin

Study Results

Participant Flow

Arm/Group Title	Arm I (Auranofin)	Arm II (Placebo)
Arm/Group Description	Patients receive auranofin PO on day 2.	Patients receive placebo PO on day 2.
Period Title: Overall Study
STARTED	15	15
COMPLETED	14	13
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Arm I (Auranofin)	Arm II (Placebo)	Total
Arm/Group Description	Patients receive auranofin PO on day 2.	Patients receive placebo PO on day 2.	Total of all reporting groups
Overall Participants	15	15	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.9 (9.0)	57.4 (9.7)	60.1 (9.6)
Sex: Female, Male (Count of Participants)
Female	12 80%	13 86.7%	25 83.3%
Male	3 20%	2 13.3%	5 16.7%
Region of Enrollment (Count of Participants)
United States	15 100%	15 100%	30 100%

Outcome Measures

1. Primary Outcome

Title	Count/Percentage of Patients Who Report Having Experienced the Paclitaxel-induced Pain Syndrome (PIAPS) for One Week After Paclitaxel After Enrollment to the Current Trial, Assessed by the Modified Brief Pain Inventory Scale (BPI)
Description	The primary endpoint is the per arm count/percentage of patients who report having experienced the PIAPS for one week after paclitaxel after enrollment to the current trial. Pain was assessed on the question 'Please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours'. The count of participants who report having experienced the PIAPS for one week after paclitaxel after enrollment to the current trial circling 'less than 4' and 'greater than or equal to 4' for each day between day 2 to day 8 are reported below. Modified Brief Pain Inventory (BPI) ranges from 0 to 10, with higher scores corresponding to more /worse pain. Fisher's Exact Test will be used to compare the frequency of patients who experienced PIAPS between the two arms.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Auranofin)	Arm II (Placebo)
Arm/Group Description	Patients receive auranofin PO on day 2.	Patients receive placebo PO on day 2.
Measure Participants	14	13
<4	10 66.7%	10 66.7%
>=4	4 26.7%	3 20%
<4	5 33.3%	7 46.7%
>=4	9 60%	6 40%
<4	2 13.3%	4 26.7%
>=4	12 80%	9 60%
<4	3 20%	7 46.7%
>=4	11 73.3%	6 40%
<4	7 46.7%	8 53.3%
>=4	7 46.7%	5 33.3%
<4	8 53.3%	8 53.3%
>=4	6 40%	5 33.3%
<4	10 66.7%	7 46.7%
>=4	4 26.7%	6 40%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Auranofin), Arm II (Placebo)
	Comments	Day 2: BPI Worst Pain Past 24 Hours
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.0
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Arm I (Auranofin), Arm II (Placebo)
	Comments	Day 3: BPI Worst Pain Past 24 Hours
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.45
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Arm I (Auranofin), Arm II (Placebo)
	Comments	Day 4: BPI Worst Pain Past 24 Hours
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.38
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Arm I (Auranofin), Arm II (Placebo)
	Comments	Day 5: BPI Worst Pain Past 24 Hours
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.12
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Arm I (Auranofin), Arm II (Placebo)
	Comments	Day 6: BPI Worst Pain Past 24 Hours
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.70
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Arm I (Auranofin), Arm II (Placebo)
	Comments	Day 7: BPI Worst Pain Past 24 Hours
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.0
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Arm I (Auranofin), Arm II (Placebo)
	Comments	Day 8: BPI Worst Pain Past 24 Hours
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.44
	Comments
	Method	Fisher Exact
	Comments

2. Primary Outcome

Title	Area Under the Curve (AUC) Summary of Worst Pain in the Last 24 Hours From Days 2 to 8
Description	Area under the curve (AUC) Summary of Worst Pain in the last 24 hours from days 2 to 8. On a scale of 0-100, with 100=Best QOL. Pain was assessed on the question 'Please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours.' Modified Brief Pain Inventory (BPI) ranges from 0 to 10, with higher scores corresponding to more pain. The AUC for this question was then calculated and ranged from 0-100, with higher scores corresponding to less/improved pain. The Equal Variance T-test will be used to compare the average AUC for worst pain between the two arms.
Time Frame	Up to 8 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Auranofin)	Arm II (Placebo)
Arm/Group Description	Patients receive auranofin PO on day 2.	Patients receive placebo PO on day 2.
Measure Participants	14	12
Mean (Standard Deviation) [score on a scale * day]	55.1 (19.0)	61.3 (21.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Auranofin), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.44
	Comments
	Method	Equal variance t-test
	Comments

3. Secondary Outcome

Title	Normalized AUC for BPI Average Pain From the Modified BPI in the Last 24 Hours From Days 2 to 8
Description	Normalized AUC for BPI Average pain from the modified BPI in the last 24 hours from days 2 to 8. On a scale of 0-100 with 100:Best QOL. Pain was assessed on the question 'Please rate your pain by circling the one number that best describes your pain on the average.' Modified Brief Pain Inventory (BPI) ranges from 0 to 10, with higher scores corresponding to more pain. The AUC for this question was then calculated and ranged from 0-100, with higher scores corresponding to less/improved pain. The Equal Variance T-test will be used to compare the average AUC for worst pain between the two arms.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Auranofin)	Arm II (Placebo)
Arm/Group Description	Patients receive auranofin PO on day 2.	Patients receive placebo PO on day 2.
Measure Participants	15	15
Mean (Standard Deviation) [score on a scale]	67.0 (17.9)	78.1 (18.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Auranofin), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.13
	Comments
	Method	Equal variance t-test
	Comments

4. Secondary Outcome

Title	Worst Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4
Description	The maximum grade for each type of toxicity will be recorded for each patient. The count of participants with worst adverse events considered at least possibly related to treatment by maximum grade are reported below.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Auranofin)	Arm II (Placebo)
Arm/Group Description	Patients receive auranofin PO on day 2.	Patients receive placebo PO on day 2.
Measure Participants	15	15
1-Mild	9 60%	7 46.7%
2-Moderate	4 26.7%	1 6.7%
3-Severe	2 13.3%	6 40%
4-Life-Threatening	0 0%	1 6.7%

5. Secondary Outcome

Title	Cramp Pain as Measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 5
Description	Cramp Pain as measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 5. The PIAPS question 'Please place a check mark (√) by all appropriate words that could be used to describe any pain you have had in the last 24 hours'. The number of participants who completed this question on day 5 were analyzed (those who checked 'cramping' are summarized by the 'Yes' row below and those who did not check 'cramping' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used.
Time Frame	Up to 5 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Auranofin)	Arm II (Placebo)
Arm/Group Description	Patients receive auranofin PO on day 2.	Patients receive placebo PO on day 2.
Measure Participants	15	15
Missing	1 6.7%	2 13.3%
No	14 93.3%	9 60%
Yes	0 0%	4 26.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Auranofin), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.025
	Comments
	Method	Chi-squared
	Comments

6. Secondary Outcome

Title	Gnawing Pain as Measure by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 8
Description	Gnawing Pain as measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 8. The PIAPS question 'Please place a check mark (√) by all appropriate words that could be used to describe any pain you have had in the last 24 hours'. The number of participants who completed this question on day 8 were analyzed (those who checked 'gnawing' are summarized by the 'Yes' row below and those who did not check 'gnawing' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used.
Time Frame	Up to 8 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Auranofin)	Arm II (Placebo)
Arm/Group Description	Patients receive auranofin PO on day 2.	Patients receive placebo PO on day 2.
Measure Participants	15	15
Missing	1 6.7%	2 13.3%
No	14 93.3%	8 53.3%
Yes	0 0%	5 33.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Auranofin), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Chi-squared
	Comments

7. Secondary Outcome

Title	Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Upper Arm Pain
Description	Location of New Pain Patient had in the last 24 hours on day 5 PIAPS Upper arm pain. PIAPS question: "Please indicate where any new pains are/were located by placing a check mark (√) next to the location. Please mark all that apply:" The number of participants who completed this question on day 5 were analyzed (those who checked 'arm, above the elbow' are summarized by the 'Yes' row below and those who did not check 'arm, above the elbow' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used.
Time Frame	Up to 5 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Auranofin)	Arm II (Placebo)
Arm/Group Description	Patients receive auranofin PO on day 2.	Patients receive placebo PO on day 2.
Measure Participants	15	15
Missing	1 6.7%	2 13.3%
No	9 60%	13 86.7%
Yes	5 33.3%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Auranofin), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	Chi-squared
	Comments

8. Secondary Outcome

Title	Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Lower Arm Pain.
Description	Location of New Pain Patient had in the last 24 hours on day 5 PIAPS Lower arm pain. PIAPS question: "Please indicate where any new pains are/were located by placing a check mark (√) next to the location. Please mark all that apply:" The number of participants who completed this question on day 5 were analyzed (those who checked 'arm, between the elbows and wrists' are summarized by the 'Yes' row below and those who did not check 'arm, between the elbows and wrists' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used.
Time Frame	Up to 5 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Auranofin)	Arm II (Placebo)
Arm/Group Description	Patients receive auranofin PO on day 2.	Patients receive placebo PO on day 2.
Measure Participants	15	15
Missing	1 6.7%	2 13.3%
No	8 53.3%	13 86.7%
Yes	6 40%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Auranofin), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Chi-squared
	Comments

9. Secondary Outcome

Title	Location of New Pain Patient Had in the Last 24 Hours on Day 6 PIAPS Lower Arm Pain.
Description	Location of New Pain Patient had in the last 24 hours on day 6 PIAPS Lower arm pain. PIAPS question: "Please indicate where any new pains are/were located by placing a check mark (√) next to the location. Please mark all that apply:" The number of participants who completed this question on day 5 were analyzed (those who checked 'arm, between the elbows and wrists' are summarized by the 'Yes' row below and those who did not check 'arm, between the elbows and wrists' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used.
Time Frame	Up to 6 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Auranofin)	Arm II (Placebo)
Arm/Group Description	Patients receive auranofin PO on day 2.	Patients receive placebo PO on day 2.
Measure Participants	15	15
Missing	1 6.7%	2 13.3%
No	10 66.7%	13 86.7%
Yes	4 26.7%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Auranofin), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Time Frame	Up to 28 days
Adverse Event Reporting Description	Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Arm/Group Title	Arm I (Auranofin)		Arm II (Placebo)
Arm/Group Description	Patients receive auranofin PO on day 2.		Patients receive placebo PO on day 2.
All Cause Mortality
	Arm I (Auranofin)		Arm II (Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Serious Adverse Events
	Arm I (Auranofin)		Arm II (Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/15 (13.3%)		5/15 (33.3%)
Blood and lymphatic system disorders
Febrile neutropenia	0/15 (0%)	0	1/15 (6.7%)	1
Gastrointestinal disorders
Abdominal pain	0/15 (0%)	0	1/15 (6.7%)	1
Infections and infestations
Urinary tract infection	0/15 (0%)	0	1/15 (6.7%)	1
Investigations
Neutrophil count decreased	1/15 (6.7%)	1	1/15 (6.7%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	0/15 (0%)	0	1/15 (6.7%)	1
Myalgia	0/15 (0%)	0	1/15 (6.7%)	1
Nervous system disorders
Syncope	0/15 (0%)	0	1/15 (6.7%)	1
Renal and urinary disorders
Renal calculi	1/15 (6.7%)	1	0/15 (0%)	0
Urinary tract obstruction	1/15 (6.7%)	1	0/15 (0%)	0
Other (Not Including Serious) Adverse Events
	Arm I (Auranofin)		Arm II (Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/15 (100%)		15/15 (100%)
Blood and lymphatic system disorders
Anemia	0/15 (0%)	0	1/15 (6.7%)	1
Gastrointestinal disorders
Diarrhea	1/15 (6.7%)	1	5/15 (33.3%)	5
Nausea	7/15 (46.7%)	7	5/15 (33.3%)	5
Vomiting	2/15 (13.3%)	2	0/15 (0%)	0
General disorders
Fatigue	14/15 (93.3%)	14	15/15 (100%)	15
Infections and infestations
Enterocolitis infectious	0/15 (0%)	0	1/15 (6.7%)	1
Investigations
Alanine aminotransferase increased	1/15 (6.7%)	1	0/15 (0%)	0
Aspartate aminotransferase increased	1/15 (6.7%)	1	0/15 (0%)	0
Neutrophil count decreased	0/15 (0%)	0	1/15 (6.7%)	1
Platelet count decreased	0/15 (0%)	0	1/15 (6.7%)	1
White blood cell decreased	0/15 (0%)	0	1/15 (6.7%)	1
Psychiatric disorders
Depression	0/15 (0%)	0	1/15 (6.7%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT 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.