Trial Outcomes & Findings for Study of Ranexa in Patients With Coronary Artery Disease and Painful Polyneuropathy (NCT NCT00832572)
NCT ID: NCT00832572
Last Updated: 2014-06-30
Results Overview
Reduction in patient-reported neuropathic pain (by 2 numeric levels as measured by the Numeric Pain Scale)
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
5 participants
Primary outcome timeframe
Baseline to Week 6
Results posted on
2014-06-30
Participant Flow
Five participants were enrolled and treated.
Participant milestones
| Measure |
Placebo/Ranolazine
Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
|
Ranolazine/Placebo
Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).
|
|---|---|---|
|
Period 1
STARTED
|
3
|
2
|
|
Period 1
COMPLETED
|
3
|
2
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
3
|
2
|
|
Period 2
COMPLETED
|
3
|
2
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Ranexa in Patients With Coronary Artery Disease and Painful Polyneuropathy
Baseline characteristics by cohort
| Measure |
Placebo/Ranolazine
n=3 Participants
Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
|
Ranolazine/Placebo
n=2 Participants
Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 6Population: Study was stopped and no analysis was performed on the primary outcome measure.
Reduction in patient-reported neuropathic pain (by 2 numeric levels as measured by the Numeric Pain Scale)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Study was stopped and no analyses were performed on the secondary outcome measures.
The participant quality of life assessed utilizing the SF-36v2 questionnaire
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Study was stopped and no analyses were performed on the secondary outcome measures.
The participant response to thermal and mechanical stimuli as measured by the Hargreaves and Von Frey tests
Outcome measures
Outcome data not reported
Adverse Events
Placebo/Ranolazine, Period 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo/Ranolazine, Period 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ranolazine/Placebo, Period 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ranolazine/Placebo, Period 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo/Ranolazine, Period 1
n=3 participants at risk
Adverse events for this reporting group are those occurring during Period 1 (participants were receiving placebo).
Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
|
Placebo/Ranolazine, Period 2
n=3 participants at risk
Adverse events for this reporting group are those occurring during Period 2 (participants were receiving ranolazine).
Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
|
Ranolazine/Placebo, Period 1
n=2 participants at risk
Adverse events for this reporting group are those occurring during Period 1 (participants were receiving ranolazine).
Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).
|
Ranolazine/Placebo, Period 2
n=2 participants at risk
Adverse events for this reporting group are those occurring during Period 2 (participants were receiving placebo).
Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).
|
|---|---|---|---|---|
|
General disorders
Fever
|
0.00%
0/3 • Up to 12 weeks
|
0.00%
0/3 • Up to 12 weeks
|
0.00%
0/2 • Up to 12 weeks
|
50.0%
1/2 • Up to 12 weeks
|
|
General disorders
Chills
|
0.00%
0/3 • Up to 12 weeks
|
0.00%
0/3 • Up to 12 weeks
|
0.00%
0/2 • Up to 12 weeks
|
50.0%
1/2 • Up to 12 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Up to 12 weeks
|
0.00%
0/3 • Up to 12 weeks
|
0.00%
0/2 • Up to 12 weeks
|
50.0%
1/2 • Up to 12 weeks
|
|
Nervous system disorders
Sensitivity to light (eyes)
|
0.00%
0/3 • Up to 12 weeks
|
0.00%
0/3 • Up to 12 weeks
|
0.00%
0/2 • Up to 12 weeks
|
50.0%
1/2 • Up to 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Right leg muscle tendon pulled
|
0.00%
0/3 • Up to 12 weeks
|
0.00%
0/3 • Up to 12 weeks
|
0.00%
0/2 • Up to 12 weeks
|
50.0%
1/2 • Up to 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Stabbing pain to right leg calf
|
0.00%
0/3 • Up to 12 weeks
|
0.00%
0/3 • Up to 12 weeks
|
0.00%
0/2 • Up to 12 weeks
|
50.0%
1/2 • Up to 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Aching pain to right calf
|
0.00%
0/3 • Up to 12 weeks
|
0.00%
0/3 • Up to 12 weeks
|
0.00%
0/2 • Up to 12 weeks
|
50.0%
1/2 • Up to 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Expiratory wheezing
|
33.3%
1/3 • Up to 12 weeks
|
0.00%
0/3 • Up to 12 weeks
|
0.00%
0/2 • Up to 12 weeks
|
0.00%
0/2 • Up to 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER