Trial · NCT00759330

Flurbiprofen Tape for Treatment of Chronic Low Back Pain

NCT00759330, Phase 2, Completed, Teikoku Pharma USA, Inc.; results first posted 2016-10-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Flurbiprofen Tape for Treatment of Chronic Low Back Pain. Trials, record NCT00759330. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00759330

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Flurbiprofen Tape for Treatment of Chronic Low Back Pain
NCT number: NCT00759330
Status: Completed
Phases: Phase 2
Enrollment: 127 participants, actual
Lead sponsor: Teikoku Pharma USA, Inc.
Conditions: Chronic Low Back Pain
Interventions: Placebo Tape (Arm 1), Flurbiprofen Tape (Arm 2), Placebo Tape (Arm 3), Flurbiprofen Tape (Arm 4)
First posted: 2008-09-25
Last updated: 2016-10-06
Results first posted: 2016-10-06

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Cumulative Summed Pain Intensity Difference (SPID+)	Days 4 and 7 of tape treatment phase	The primary efficacy endpoint was the cumulative summed pain intensity difference (SPID+) at Days 4 and 7 of the tape treatment phase as computed from the daily categorical pain scale score reported on the patient's daily diary during the tape treatment phase; pain was rated on an 11-point scale, where: 0 = no pain, 10 = worst pain imaginable. Summed pain intensity difference is the sum of the pain intensity differences (PID). PID at each post-baseline evaluation was computed as the average baseline categorical pain scale score minus the post-baseline categorical pain scale score from the daily dairy. For patients with multiple pain scores reported on a given post-baseline study day, the PID scores were averaged to compute one daily PID score for each patient.
Secondary	Pain Intensity Difference (PID+)	Days 1 through 7 of tape treatment phase	+PID = pre-treatment value at baseline - post-treatment value at day of evaluation, where: pre-treatment value at baseline = average daily pain over the last 3 days of the baseline phase (ie, average of daily averages of the categorical pain scale scores for the last 3 days of the baseline phase). Pain was rated on an 11-point scale, where: 0 = no pain, 10 = worst pain imaginable. A positive PID indicates a reduction in pain.
Secondary	Average Daily Categorical Pain Scale Scores	Days 1 through 7 of tape treatment phase	Patients rated their lower back pain, caused by normal activity and movement, on an 11-point categorical pain scale, where: 0 = no pain, and 10 = worst pain imaginable. Patients rated their lower back pain every 12 hours, at any time they took medication including rescue medication for any type of pain, and if they applied or removed their treatment tapes at a time other than the scheduled time. Data are reported as the daily average categorical pain scale score by treatment group.
Secondary	Percent Change From Baseline in Total Functional Rating Index (FRI)	baseline to Day 7 of tape treatment phase	Patients completed the FRI, a 10-item back pain-specific measure of function questionnaire describing the condition at the time the questionnaire was completed; each item (pain intensity, sleeping, personal care, travel, etc.) was rated on a 5-point scale, where 0 = best outcome, 4 = worst outcome. FRI was reported as the percent change from baseline at Day 7 of the tape treatment phase, where: Total FRI score = sum of the 10 questions. The total FRI score ranged from 0 (best outcome) to 40 (worst outcome). Percent change = (\[baseline - Day 7\]/baseline)\*100. A positive percent change indicates a favorable treatment effect.
Secondary	Change From Baseline in Total Tender Point Examination Score	Baseline to Day 7 of tape treatment phase	At baseline and Day 7 of the tape treatment phase, patients had an assessment of tenderness bilaterally at the sacroiliac joint, greater trochanter of the hip, gluteus medius and minimus, and paraspinal muscles at L3-L4, L4-L5, and L5-S1. The investigator or research nurse pressed 12 specific areas of the body (6 locations, left and right sides), and patients were asked to rate the intensity of their pain at those 12 areas using an 11-point scale, where: 0 = no pain, 10 = the worst pain the patient has ever experienced. The total tender point examination score ranged from 0 (best outcome) to 120 (worst outcome). Change from baseline = baseline - Day 7. A positive change indicates a favorable treatment effect.
Secondary	Patient Global Impression of Change (PGIC)	Day 7	At Day 7, patients provided their PGIC with regard to lower back pain response to treatment, using a 7-point scale, where: 1 = very much improved, 7 = very much worse.
Secondary	Acetaminophen Used During the Tape Treatment Phase	Day 1 through Day 7 of the tape treatment phase	The percentage of patients who used rescue medication during the tape treatment phase.
Secondary	Acetaminophen Used During the Tape Treatment Phase	Day 1 through Day 7 of the tape treatment phase	The total amount (mg) of rescue medication used during the tape treatment phase.
Secondary	Percentage of Patients Who Discontinued	Days 1 through Day 7 of tape treatment phase	The percentage of patients who discontinued the study during the tape treatment phase due to lack of efficacy.
Secondary	Patient Assessment of Wearability of Therapy	Day 7	At Day 7, patients assessed the wearability of their treatment tape (ease of application, stays in place, comfortable to wear) using a 4-point scale, where: 1 = Excellent, 4 = Poor.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Cumulative Summed Pain Intensity Difference (SPID+)	Days 4 and 7 of tape treatment phase	Reported data are based on Intent-to-Treat patient population.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Pain Intensity Difference (PID+)	Days 1 through 7 of tape treatment phase	Reported data are based on Intent-to-Treat patient population.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Average Daily Categorical Pain Scale Scores	Days 1 through 7 of tape treatment phase	Reported data are based on Intent-to-Treat patient population.	units on a scale	MEAN
SECONDARY	Percent Change From Baseline in Total Functional Rating Index (FRI)	baseline to Day 7 of tape treatment phase	Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group).	percent change from baseline	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Total Tender Point Examination Score	Baseline to Day 7 of tape treatment phase	Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group).	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Patient Global Impression of Change (PGIC)	Day 7	Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group).	participants	NUMBER
SECONDARY	Acetaminophen Used During the Tape Treatment Phase	Day 1 through Day 7 of the tape treatment phase	Reported data are based on Intent-to-Treat patient population.	percentage of patients	NUMBER
SECONDARY	Acetaminophen Used During the Tape Treatment Phase	Day 1 through Day 7 of the tape treatment phase	Reported data are based on Intent-to-Treat patient population.	mg	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Patients Who Discontinued	Days 1 through Day 7 of tape treatment phase	Reported data are based on Intent-to-Treat patient population.	percentage of patients who discontinued	NUMBER
SECONDARY	Patient Assessment of Wearability of Therapy	Day 7	Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group).	participants	NUMBER

Source ClinicalTrials.gov

Results by group160

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Cumulative Summed Pain Intensity Difference (SPID+)	Placebo Tape, Daily for 12 Hours	SPID for Day 4	4.6	Standard Error 1.62	units on a scale
Cumulative Summed Pain Intensity Difference (SPID+)	Flurbiprofen Tape, Daily for 12 Hours	SPID for Day 4	6.3	Standard Error 1.14	units on a scale
Cumulative Summed Pain Intensity Difference (SPID+)	Placebo Tape, Daily for 24 Hours	SPID for Day 4	6.7	Standard Error 1.56	units on a scale
Cumulative Summed Pain Intensity Difference (SPID+)	Flurbiprofen Tape, Daily for 24 Hours	SPID for Day 4	5.2	Standard Error 1.13	units on a scale
Cumulative Summed Pain Intensity Difference (SPID+)	Placebo Tape, Daily for 12 Hours	SPID for Day 7	8.4	Standard Error 2.95	units on a scale
Cumulative Summed Pain Intensity Difference (SPID+)	Flurbiprofen Tape, Daily for 12 Hours	SPID for Day 7	12.1	Standard Error 2.06	units on a scale
Cumulative Summed Pain Intensity Difference (SPID+)	Placebo Tape, Daily for 24 Hours	SPID for Day 7	13.0	Standard Error 2.82	units on a scale
Cumulative Summed Pain Intensity Difference (SPID+)	Flurbiprofen Tape, Daily for 24 Hours	SPID for Day 7	10.2	Standard Error 2.05	units on a scale
Pain Intensity Difference (PID+)	Placebo Tape, Daily for 12 Hours	Day 1	0.9	Standard Error 0.38	units on a scale
Pain Intensity Difference (PID+)	Flurbiprofen Tape, Daily for 12 Hours	Day 1	1.3	Standard Error 0.26	units on a scale

1 to 10 of 160Source ClinicalTrials.gov

See all 160 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo Tape, Daily for 12 Hours	20
Overall Study	STARTED	Flurbiprofen Tape, Daily for 12 Hours	42
Overall Study	STARTED	Placebo Tape, Daily for 24 Hours	22
Overall Study	STARTED	Flurbiprofen Tape, Daily for 24 Hours	43
Overall Study	COMPLETED	Placebo Tape, Daily for 12 Hours	19
Overall Study	COMPLETED	Flurbiprofen Tape, Daily for 12 Hours	41
Overall Study	COMPLETED	Placebo Tape, Daily for 24 Hours	22
Overall Study	COMPLETED	Flurbiprofen Tape, Daily for 24 Hours	41
Overall Study	NOT COMPLETED	Placebo Tape, Daily for 12 Hours	1
Overall Study	NOT COMPLETED	Flurbiprofen Tape, Daily for 12 Hours	1

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events56

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Stomach discomfort	Gastrointestinal disorders	Placebo Tape, Daily for 12 Hours	0	20
other	Stomach discomfort	Gastrointestinal disorders	Flurbiprofen Tape, Daily for 12 Hours	1	42
other	Stomach discomfort	Gastrointestinal disorders	Placebo Tape, Daily for 24 Hours	2	22
other	Stomach discomfort	Gastrointestinal disorders	Flurbiprofen Tape, Daily for 24 Hours	0	43
other	Application site erythema	General disorders	Placebo Tape, Daily for 12 Hours	0	20
other	Application site erythema	General disorders	Flurbiprofen Tape, Daily for 12 Hours	1	42
other	Application site erythema	General disorders	Placebo Tape, Daily for 24 Hours	4	22
other	Application site erythema	General disorders	Flurbiprofen Tape, Daily for 24 Hours	5	43
other	Application site irritation	General disorders	Placebo Tape, Daily for 12 Hours	2	20
other	Application site irritation	General disorders	Flurbiprofen Tape, Daily for 12 Hours	4	42

1 to 10 of 56Source ClinicalTrials.gov

See all 56 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo Tape, Daily for 12 Hours
Total, all-cause mortality	Flurbiprofen Tape, Daily for 12 Hours
Total, all-cause mortality	Placebo Tape, Daily for 24 Hours
Total, all-cause mortality	Flurbiprofen Tape, Daily for 24 Hours
Total, other adverse events	Placebo Tape, Daily for 12 Hours	9	20
Total, other adverse events	Flurbiprofen Tape, Daily for 12 Hours	11	42
Total, other adverse events	Placebo Tape, Daily for 24 Hours	12	22
Total, other adverse events	Flurbiprofen Tape, Daily for 24 Hours	11	43
Total, serious adverse events	Placebo Tape, Daily for 12 Hours	0	20
Total, serious adverse events	Flurbiprofen Tape, Daily for 12 Hours	0	42

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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