NCT01045993CompletedNot Applicable
A Pilot Study To Evaluate Various Methodologies For Assessing The Treatment Of Low Back Pain
Wyeth is now a wholly owned subsidiary of Pfizer1 site in 1 country61 target enrollmentStarted: February 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Time to First Perceptible Relief (Confirmed by Meaningful Relief)
Study Overview
Brief Summary
The study is designed to assess methods used in clinical research.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Lower back pain
- •Male or female in generally good health, from 18 to 55 years of age (inclusive)
Exclusion Criteria
- •Pregnant or lactating
- •Subject has evidence or history of radiculopathy, i.e. sciatica extending below the knee (numbness, tingling, or shooting pain), or other neurologic deficits (abnormal straight leg raise test, patellar reflexes, and/or bowel and bladder function);
- •Subject has a history of previous back surgery;
- •Subject has back pain resulting from traumatic injury involving physical evidence of bruising, swelling, or inflammation to the abdomen or low back area which occurred less than 48 hours prior to enrollment
- •Has taken an investigational drug within the past 30 days prior to entering the study, or currently enrolled in another investigational study
- •Is a member or relative of the study site staff, CRO or Sponsor organization directly involved with the study or had a household member or relative participate concurrently or previously in this study
- •Has previously been enrolled in this study
Arms & Interventions
1
Active Comparator
Heat device
Intervention: Heat Device (Device)
2
Sham Comparator
Placebo arm
Intervention: Sham Device (Device)
3
Active Comparator
Marketed analgesic
Intervention: marketed analgesic (Drug)
4
Placebo Comparator
(Oral) Placebo comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Time to First Perceptible Relief (Confirmed by Meaningful Relief)
Time Frame: Baseline (time of wrap application or oral treatment administration) up to 4 hours
"First perceptible relief" defined as the elapsed time from wrap application or oral treatment until the participant depressed the first stopwatch labeled "first perceptible relief" (any pain relieving effect), provided the participant also depressed the second stopwatch labeled "meaningful relief" (meaningful to participant) by the end of the scheduled in-patient evaluation (4 hours / 240 minutes). If the confirmation was not achieved, the participant was censored at the time when the first stopwatch was depressed. Confidence interval (CI) calculated using the method of Simon \& Lee.
Secondary Outcomes
- Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Extension(Baseline (time of wrap application or oral treatment administration) and 4 hours)
- Time to Meaningful Relief(Baseline (time of wrap application or oral treatment administration) up to 4 hours)
- Time Weighted Sum of Pain Relief From 0 Through 8 Hours (TOTPAR 0-8)(Baseline (time of wrap application or oral treatment administration) up to 8 hours)
- Time Weighted Sum of Change From Baseline in the Back Stiffness Score Over 8 Hours(Baseline (time of wrap application or oral treatment administration) up to 8 hours)
- Time to Treatment Failure(Baseline (time of wrap application or oral treatment administration) up to 8 hours)
- Individual Time-Point Pain Relief Scores(At 60, 120, 180, 240, 300, 360, 420, and 480 minutes)
- Change From Baseline in Individual Time-point Back Stiffness Scores(At 60, 120, 180, 240, 300, 360, 420, and 480 minutes)
- Change From Baseline (Bsl) in Combined Flexibility Score: Extension(Baseline (time of wrap application or oral treatment administration) and 4 hours)
- Change From Baseline (Bsl) in Overall Combined Flexibility Score: Side-to-Side(Baseline (time of wrap application or oral treatment administration) and 4 hours)
- Change From Baseline (Bsl) in Overall Combined Flexibility Score: Rotation(Baseline (time of wrap application or oral treatment administration) and 4 hours)
- Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Side-to-Side(Baseline (time of wrap application or oral treatment administration) and 4 hours)
- Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Rotation(Baseline (time of wrap application or oral treatment administration) and 4 hours)
- Change From Baseline (Bsl) in Pain Measurement for Flexibility Measure: Extension(Baseline (time of wrap application or oral treatment administration) and 4 hours)
- Change From Baseline in Pain Measurement for Flexibility Measure: Side-to-Side(Baseline (time of wrap application or oral treatment administration) and 4 hours)
- Change From Baseline in Pain Measurement for Flexibility Measure: Rotation(Baseline (time of wrap application or oral treatment administration) and 4 hours)
- Number of Participants Per Categorical Score for Global Assessment of Study Treatment(Baseline (time of wrap application or oral treatment administration) up to 8 hours)
Investigators
Study Sites (1)
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