Trial Outcomes & Findings for A Study to Collect Data About Analgesia in Patients With Bone Metastasis (NCT NCT02774213)
NCT ID: NCT02774213
Last Updated: 2019-08-19
Results Overview
11-point Numeric Rating Scale from 0 to 10 with 0 meaning no pain and 10 pain as bad as you can imagine; baseline measure was the Weekly Average Pain Score (WAPS), over the week first visit (the last 7 days); end of study measure was the mean of the APS of the last 7 days prior to last visit (Visit 2)
COMPLETED
74 participants
Time zero equals baseline up to after at least 4 weeks of observation (Visit 2)
2019-08-19
Participant Flow
Participant milestones
| Measure |
Cancer-Induced Bone Pain (CIBP)
Cancer patients with bone metastasis suffering from pain
|
|---|---|
|
Overall Study
STARTED
|
74
|
|
Overall Study
COMPLETED
|
55
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only subjects completing the study per protocol were analysed
Baseline characteristics by cohort
| Measure |
Cancer-Induced Bone Pain (CIBP)
n=74 Participants
Cancer patients with bone metastasis suffering from pain
|
|---|---|
|
Age, Continuous
|
60.1 years
n=74 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=53 Participants • Only subjects completing the study per protocol were analysed
|
|
Sex: Female, Male
Male
|
11 Participants
n=53 Participants • Only subjects completing the study per protocol were analysed
|
PRIMARY outcome
Timeframe: Time zero equals baseline up to after at least 4 weeks of observation (Visit 2)Population: Only the patients completing the study per protocol were analyzed. APS was available for 47 patients amongst the per protocol completers.
11-point Numeric Rating Scale from 0 to 10 with 0 meaning no pain and 10 pain as bad as you can imagine; baseline measure was the Weekly Average Pain Score (WAPS), over the week first visit (the last 7 days); end of study measure was the mean of the APS of the last 7 days prior to last visit (Visit 2)
Outcome measures
| Measure |
Cancer-Induced Bone Pain (CIBP)
n=47 Participants
Cancer patients with bone metastasis suffering from pain
|
|---|---|
|
Patient's Change From Baseline of Pain Severity, as Measured by the Weekly Means of the Daily Average Pain Scores (APS)
|
2.26 units on a scale
Standard Deviation 2.95
|
SECONDARY outcome
Timeframe: Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)Population: Only the patients completing the study per protocol were analyzed. WPS was available for 46 patients amongst the per protocol completers.
11-point Numeric Rating Scale from 0 to 10 with 0 meaning no pain and 10 pain as bad as you can imagine; baseline measure was was the mean of the WPS of the first 7 days after first visit (Visit 1); end of study measure was the mean of the WPS of the last 7 days prior to last visit (Visit 2)
Outcome measures
| Measure |
Cancer-Induced Bone Pain (CIBP)
n=46 Participants
Cancer patients with bone metastasis suffering from pain
|
|---|---|
|
Patient's Change From Baseline of Pain Severity, as Measured by the Weekly Means of the Daily Worst Pain Score (WPS)
|
1.23 units on a scale
Standard Deviation 2.07
|
SECONDARY outcome
Timeframe: Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)Population: Only the patients completing the study per protocol were analyzed. APS was available for 51 patients amongst the per protocol completers.
The pain severity score of BPI is an arithmetic average of the 4 severity scores reported on an 11- point NRS going from 0 (no pain) to 10 (pain as bad as you can imagine). The BPI severity questions are: 3\. Your pain at its worst in the last 24 hours? 4. Your pain at its least in the last 24 hours? 5. Your pain on the average? 6. How much pain you have right now?
Outcome measures
| Measure |
Cancer-Induced Bone Pain (CIBP)
n=51 Participants
Cancer patients with bone metastasis suffering from pain
|
|---|---|
|
Patient's Change From Baseline of Pain Severity as Measured by the Brief Pain Inventory (BPI)
|
1.16 score on a scale
Standard Deviation 2.11
|
SECONDARY outcome
Timeframe: Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)Population: Only the patients completing the study per protocol were analyzed. IGAC was available for 48 patients amongst the per protocol completers.
Investigator subjective evaluation of patient condition using an 11-point NRS with 0 meaning best and 10 worst
Outcome measures
| Measure |
Cancer-Induced Bone Pain (CIBP)
n=48 Participants
Cancer patients with bone metastasis suffering from pain
|
|---|---|
|
Patient's Change From Baseline of Investigator Global Assessment of Changes (IGAC)
|
1.31 units on a scale
Standard Deviation 2.42
|
SECONDARY outcome
Timeframe: Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)Population: Only the patients completing the study per protocol were analyzed. PGAC was available for 50 patients amongst the per protocol completers.
Patient subjective evaluation of patient condition using an 11-point NRS with 0 meaning best and 10 worst
Outcome measures
| Measure |
Cancer-Induced Bone Pain (CIBP)
n=50 Participants
Cancer patients with bone metastasis suffering from pain
|
|---|---|
|
Patient's Change From Baseline of Patient Global Assessment of Changes (PGAC)
|
1.22 units on a scale
Standard Deviation 2.64
|
SECONDARY outcome
Timeframe: Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)Number of symptoms measured after Clinical Pain Assessments (CPAs), 0 no symptom to 3 all the three symptoms : Hyperalgesia, Hypoesthesia, and Sensory loss.
Outcome measures
| Measure |
Cancer-Induced Bone Pain (CIBP)
n=67 Participants
Cancer patients with bone metastasis suffering from pain
|
|---|---|
|
Patient's Change From Baseline of Pain Intensity Measured After Clinical Pain Assessments (CPAs)
|
0.34 Number of symptoms
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)Pain scale of the Quality-of-Life Questionnaire in 30 questions (QLQ-C30); 2 items in the Pain scale ranging each from 1 to 4 (high score for a symptom scale / item represents a high level of symptomatology / problems); Pain score is sum of of the 2 items
Outcome measures
| Measure |
Cancer-Induced Bone Pain (CIBP)
n=51 Participants
Cancer patients with bone metastasis suffering from pain
|
|---|---|
|
Patient's Change From Baseline of Quality-of-Life Questionnaire in 30 Questions (QLQ-C30).
|
-5.99 score on a scale
Standard Deviation 13.81
|
SECONDARY outcome
Timeframe: Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)The pain interference score of BPI is an arithmetic average of the 7 interference scores reported on an 11-point NRS going from 0 (does not interfere) to 10 (completely interferes) The BPI interference questions are: 9\. Pain has interfered in the last 24 hours with 1. General Activity? 2. Mood? 3. Walking Abililty? 4. Work? 5. Relations with other people? 6. Sleep? 7. Enjoyment of life?
Outcome measures
| Measure |
Cancer-Induced Bone Pain (CIBP)
n=51 Participants
Cancer patients with bone metastasis suffering from pain
|
|---|---|
|
Patient's Change From Baseline of Pain Interference as Measured by the Brief Pain Inventory (BPI)
|
1.42 score on a scale
Standard Deviation 2.55
|
Adverse Events
Cancer-Induced Bone Pain (CIBP)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60