Trial Outcomes & Findings for Efficacy of Pregabalin in Patients With Radicular Pain (NCT NCT00908375)

NCT ID: NCT00908375

Last Updated: 2014-10-13

Results Overview

Standard numeric rating pain scale ranging from 0 (no pain) to 10 (worst pain imaginable) after 3 weeks of treatment. .

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 39 participants
• Primary outcome timeframe: 3 weeks
• Results posted on: 2014-10-13

Participant Flow

Participant milestones

Measure	Pregabalin A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks. Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.	Sugar Pill One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks. Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.
Overall Study STARTED	20	19
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	10	10

Reasons for withdrawal

Measure	Pregabalin A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks. Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.	Sugar Pill One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks. Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.
Overall Study Withdrawal by Subject	2	4
Overall Study Lost to Follow-up	8	6

Baseline Characteristics

Efficacy of Pregabalin in Patients With Radicular Pain

Baseline characteristics by cohort

Measure	Pregabalin n=20 Participants A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks. Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.	Sugar Pill n=19 Participants One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks. Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.	Total n=39 Participants Total of all reporting groups
Age, Continuous	47 years STANDARD_DEVIATION 10.17 • n=5 Participants	44 years STANDARD_DEVIATION 13.38 • n=7 Participants	45 years STANDARD_DEVIATION 11.78 • n=5 Participants
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	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Pain Score (Numeric Rating Scale , 0-10)	6.5 units on a scale n=5 Participants	6 units on a scale n=7 Participants	6 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks

Standard numeric rating pain scale ranging from 0 (no pain) to 10 (worst pain imaginable) after 3 weeks of treatment.

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Outcome measures

Measure	Pregabalin n=10 Participants A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks. Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.	Sugar Pill n=9 Participants One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks. Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.
Pain Scores (NRS) at 3-weeks	6 units on a scale Interval 1.0 to 9.0	3 units on a scale Interval 0.0 to 8.0

SECONDARY outcome

Timeframe: 3 weeks

Global impression of change in patient status reported at 3 weeks. The global impression of change consists of a Likert scale as below:

1. Very Much Improved

2. Much Improved

3. Minimally Improved

4. No Change

5. Minimally Worse

6. Much Worse

7. Very Much Worse

Outcome measures

Measure	Pregabalin n=10 Participants A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks. Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.	Sugar Pill n=9 Participants One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks. Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.
Patient's Global Impression of Change at 3 Weeks	3.5 units on a scale Interval 1.0 to 5.0	3 units on a scale Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: 3 weeks

Oswestry disability index (ODI) is a tool to measure a subject's functional disability. The Oswestry disability index consists of 10 questions with a Likert 0-5 scale. Each individual score is converted into a percent which represents the "percent disability." There are five tiers, 0-20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled), 81%-100% (i.e. bed bound). We report the Oswestry disability scores at 3 weeks.

Outcome measures

Measure	Pregabalin n=10 Participants A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks. Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.	Sugar Pill n=9 Participants One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks. Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.
Oswestry Disability Questionnaires	41 percent disability Interval 8.0 to 64.0	20 percent disability Interval 2.0 to 60.0

Adverse Events

Pregabalin

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Sugar Pill

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pregabalin n=20 participants at risk A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks. Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.	Sugar Pill n=19 participants at risk One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks. Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.
Cardiac disorders Palpitations	0.00% 0/20 • Subject reported difficulty in swallowing sensation 4 days following the start of the study. Symptoms resolved within 48 hrs following discontinuation of the study drug.	5.3% 1/19 • Number of events 1 • Subject reported difficulty in swallowing sensation 4 days following the start of the study. Symptoms resolved within 48 hrs following discontinuation of the study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/20 • Subject reported difficulty in swallowing sensation 4 days following the start of the study. Symptoms resolved within 48 hrs following discontinuation of the study drug.	5.3% 1/19 • Number of events 1 • Subject reported difficulty in swallowing sensation 4 days following the start of the study. Symptoms resolved within 48 hrs following discontinuation of the study drug.
Nervous system disorders Headache	5.0% 1/20 • Number of events 1 • Subject reported difficulty in swallowing sensation 4 days following the start of the study. Symptoms resolved within 48 hrs following discontinuation of the study drug.	0.00% 0/19 • Subject reported difficulty in swallowing sensation 4 days following the start of the study. Symptoms resolved within 48 hrs following discontinuation of the study drug.

Other adverse events

Adverse event data not reported

Additional Information

K Malik

Northwestern University

Phone: 3129262280

Email: kmalikmd@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place