Trial Outcomes & Findings for Orphenadrine and Methocarbamol for LBP (NCT NCT02665286)

NCT ID: NCT02665286

Last Updated: 2018-06-26

Results Overview

Change in Roland Morris Disability Questionnaire between baseline and 1 week. The low back pain functional disability scale is the RMDQ. The RMDQ is a 24-item low back pain functional scale recommended for use in low back pain research.Higher scores signify greater low back-related functional impairment.0= no functional impairment, 24= severe functional impairment.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 240 participants
• Primary outcome timeframe: 1 week
• Results posted on: 2018-06-26

Participant Flow

Participant milestones

Measure	Placebo Naproxen 500mg po BID x 10 days #20 + Placebo Naproxen: Naproxen 500mg PO BID x 7 days Placebo: 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days	Orphenadrine Naproxen 500mg po BID x 10 days #20 + Orphenadrine Orphenadrine: Orphenadrine 100mg PO BID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days	Methocarbamol Naproxen 500mg po BID x 10 days #20 + Methocarbamol Methocarbamol: Methocarbamol 750mg 1-2 tabs po TID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days
Overall Study STARTED	79	80	81
Overall Study COMPLETED	76	78	80
Overall Study NOT COMPLETED	3	2	1

Reasons for withdrawal

Measure	Placebo Naproxen 500mg po BID x 10 days #20 + Placebo Naproxen: Naproxen 500mg PO BID x 7 days Placebo: 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days	Orphenadrine Naproxen 500mg po BID x 10 days #20 + Orphenadrine Orphenadrine: Orphenadrine 100mg PO BID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days	Methocarbamol Naproxen 500mg po BID x 10 days #20 + Methocarbamol Methocarbamol: Methocarbamol 750mg 1-2 tabs po TID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days
Overall Study Lost to Follow-up	3	2	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Placebo n=79 Participants Naproxen 500mg po BID x 10 days #20 + Placebo Naproxen: Naproxen 500mg PO BID x 7 days Placebo: 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days	Orphenadrine n=80 Participants Naproxen 500mg po BID x 10 days #20 + Orphenadrine Orphenadrine: Orphenadrine 100mg PO BID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days	Methocarbamol n=81 Participants Naproxen 500mg po BID x 10 days #20 + Methocarbamol Methocarbamol: Methocarbamol 750mg 1-2 tabs po TID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days	Total n=240 Participants Total of all reporting groups
Age, Continuous	39 years STANDARD_DEVIATION 12 • n=79 Participants	40 years STANDARD_DEVIATION 12 • n=80 Participants	38 years STANDARD_DEVIATION 12 • n=81 Participants	39 years STANDARD_DEVIATION 12 • n=240 Participants
Sex: Female, Male Female	34 Participants n=79 Participants	34 Participants n=80 Participants	41 Participants n=81 Participants	109 Participants n=240 Participants
Sex: Female, Male Male	45 Participants n=79 Participants	46 Participants n=80 Participants	40 Participants n=81 Participants	131 Participants n=240 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	79 Participants n=79 Participants	80 Participants n=80 Participants	81 Participants n=81 Participants	240 Participants n=240 Participants
Duration of Back Pain Prior to Study	48 Hours n=79 Participants	72 Hours n=80 Participants	48 Hours n=81 Participants	48 Hours n=240 Participants

PRIMARY outcome

Timeframe: 1 week

Change in Roland Morris Disability Questionnaire between baseline and 1 week.

The low back pain functional disability scale is the RMDQ. The RMDQ is a 24-item low back pain functional scale recommended for use in low back pain research.Higher scores signify greater low back-related functional impairment.0= no functional impairment, 24= severe functional impairment.

Outcome measures

Measure	Placebo n=76 Participants Naproxen 500mg po BID x 10 days #20 + Placebo Naproxen: Naproxen 500mg PO BID x 7 days Placebo: 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days	Orphenadrine n=78 Participants Naproxen 500mg po BID x 10 days #20 + Orphenadrine Orphenadrine: Orphenadrine 100mg PO BID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days	Methocarbamol n=80 Participants Naproxen 500mg po BID x 10 days #20 + Methocarbamol Methocarbamol: Methocarbamol 750mg 1-2 tabs po TID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days
Functional Impairment as Measured on the Roland Morris Disability Questionnaire	10.9 units on a scale Interval 8.9 to 12.9	9.4 units on a scale Interval 7.4 to 11.5	8.1 units on a scale Interval 6.1 to 10.1

SECONDARY outcome

Timeframe: 1 week

Participants with moderate to severe low back pain after treatment as report on the following ordinal scale: severe, moderate, mild, or none

Outcome measures

Measure	Placebo n=76 Participants Naproxen 500mg po BID x 10 days #20 + Placebo Naproxen: Naproxen 500mg PO BID x 7 days Placebo: 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days	Orphenadrine n=78 Participants Naproxen 500mg po BID x 10 days #20 + Orphenadrine Orphenadrine: Orphenadrine 100mg PO BID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days	Methocarbamol n=80 Participants Naproxen 500mg po BID x 10 days #20 + Methocarbamol Methocarbamol: Methocarbamol 750mg 1-2 tabs po TID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days
Cases of Moderate or Severe LBP	34 Participants	26 Participants	31 Participants

SECONDARY outcome

Timeframe: 1 week

Participants still using medication such as analgesics for LBP after treatment

Outcome measures

Measure	Placebo n=76 Participants Naproxen 500mg po BID x 10 days #20 + Placebo Naproxen: Naproxen 500mg PO BID x 7 days Placebo: 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days	Orphenadrine n=78 Participants Naproxen 500mg po BID x 10 days #20 + Orphenadrine Orphenadrine: Orphenadrine 100mg PO BID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days	Methocarbamol n=80 Participants Naproxen 500mg po BID x 10 days #20 + Methocarbamol Methocarbamol: Methocarbamol 750mg 1-2 tabs po TID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days
Medications--Patient Self Report of Medication Use	42 Participants	40 Participants	50 Participants

SECONDARY outcome

Timeframe: 1 week

The number of participants with affirmative response to the following question: Do you want the same medication combination during a subsequent episode of LBP. This is a patient-centered outcome that allows each individual to determine the desirability of the intervention.

Outcome measures

Measure	Placebo n=75 Participants Naproxen 500mg po BID x 10 days #20 + Placebo Naproxen: Naproxen 500mg PO BID x 7 days Placebo: 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days	Orphenadrine n=78 Participants Naproxen 500mg po BID x 10 days #20 + Orphenadrine Orphenadrine: Orphenadrine 100mg PO BID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days	Methocarbamol n=78 Participants Naproxen 500mg po BID x 10 days #20 + Methocarbamol Methocarbamol: Methocarbamol 750mg 1-2 tabs po TID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days
Patient Satisfaction With Treatment	51 Participants	53 Participants	51 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Orphenadrine

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Methocarbamol

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=76 participants at risk Naproxen 500mg po BID x 10 days #20 + Placebo Naproxen: Naproxen 500mg PO BID x 7 days Placebo: 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days	Orphenadrine n=78 participants at risk Naproxen 500mg po BID x 10 days #20 + Orphenadrine Orphenadrine: Orphenadrine 100mg PO BID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days	Methocarbamol n=80 participants at risk Naproxen 500mg po BID x 10 days #20 + Methocarbamol Methocarbamol: Methocarbamol 750mg 1-2 tabs po TID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days
Nervous system disorders Drowsy	6.6% 5/76 • Number of events 5 • 1 week after treatment	10.3% 8/78 • Number of events 8 • 1 week after treatment	16.2% 13/80 • Number of events 13 • 1 week after treatment
Nervous system disorders dizz	2.6% 2/76 • Number of events 2 • 1 week after treatment	3.8% 3/78 • Number of events 3 • 1 week after treatment	5.0% 4/80 • Number of events 4 • 1 week after treatment
Gastrointestinal disorders Stomach irritation	1.3% 1/76 • Number of events 1 • 1 week after treatment	1.3% 1/78 • Number of events 1 • 1 week after treatment	5.0% 4/80 • Number of events 4 • 1 week after treatment
Gastrointestinal disorders Nausea	1.3% 1/76 • Number of events 1 • 1 week after treatment	0.00% 0/78 • 1 week after treatment	3.8% 3/80 • Number of events 3 • 1 week after treatment

Additional Information

Benjamin W. Friedman, MD, MS

Montefiore Medical Center

Phone: (718)920-6266

Email: befriedm@montefiore.org

Results disclosure agreements

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