Trial Outcomes & Findings for Phase 2 Chronic Low Back Pain Study (NCT NCT01364922)
NCT ID: NCT01364922
Last Updated: 2014-01-29
Results Overview
The change from the double-blind randomization baseline (DB baseline: the last assessment before first dose in the double-blind period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from an ANCOVA model.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
168 participants
Primary outcome timeframe
Double-blind baseline to Day 29
Results posted on
2014-01-29
Participant Flow
Participant milestones
| Measure |
Open-label Hydrocodone/Acetaminophen Extended Release
2 hydrocodone/acetaminophen extended release tablets, twice daily, for 2 weeks.
|
Double-blind Hydrocodone/Acetaminophen Extended Release
1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks.
|
Double-blind Placebo
1 placebo tablet, twice daily, for 2 weeks.
|
|---|---|---|---|
|
Open-label (OL) Period
STARTED
|
168
|
0
|
0
|
|
Open-label (OL) Period
COMPLETED
|
146
|
0
|
0
|
|
Open-label (OL) Period
NOT COMPLETED
|
22
|
0
|
0
|
|
Double-Blind (DB) Period
STARTED
|
0
|
99
|
47
|
|
Double-Blind (DB) Period
COMPLETED
|
0
|
94
|
42
|
|
Double-Blind (DB) Period
NOT COMPLETED
|
0
|
5
|
5
|
Reasons for withdrawal
| Measure |
Open-label Hydrocodone/Acetaminophen Extended Release
2 hydrocodone/acetaminophen extended release tablets, twice daily, for 2 weeks.
|
Double-blind Hydrocodone/Acetaminophen Extended Release
1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks.
|
Double-blind Placebo
1 placebo tablet, twice daily, for 2 weeks.
|
|---|---|---|---|
|
Open-label (OL) Period
Adverse Event
|
7
|
0
|
0
|
|
Open-label (OL) Period
Did Not Meet Randomization Criteria
|
6
|
0
|
0
|
|
Open-label (OL) Period
Withdrawal by Subject
|
4
|
0
|
0
|
|
Open-label (OL) Period
Lack of Efficacy
|
3
|
0
|
0
|
|
Open-label (OL) Period
Lost to Follow-up
|
1
|
0
|
0
|
|
Open-label (OL) Period
Other, Unspecified
|
1
|
0
|
0
|
|
Double-Blind (DB) Period
Lack of Efficacy
|
0
|
3
|
4
|
|
Double-Blind (DB) Period
Subject Noncompliant
|
0
|
1
|
0
|
|
Double-Blind (DB) Period
Adverse Event
|
0
|
0
|
1
|
|
Double-Blind (DB) Period
Other, Unspecified
|
0
|
1
|
0
|
Baseline Characteristics
Phase 2 Chronic Low Back Pain Study
Baseline characteristics by cohort
| Measure |
OL Hydrocodone/Acetaminophen Extended Release (Nonrandomized)
n=22 Participants
2 hydrocodone/acetaminophen extended release tablets, twice daily, for 2 weeks. These participants enrolled in the study and received at least one dose of study drug during the open-label period; these participants were not randomized and did not progress to the double-blind period.
|
DB Hydrocodone/Acetaminophen Extended Release
n=99 Participants
1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive hydrocodone/acetaminophen extended release during the double-blind period.
|
DB Placebo
n=47 Participants
1 placebo tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive placebo during the double-blind period.
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.0 years
STANDARD_DEVIATION 13.82 • n=5 Participants
|
47.9 years
STANDARD_DEVIATION 13.62 • n=7 Participants
|
52.7 years
STANDARD_DEVIATION 13.82 • n=5 Participants
|
49.7 years
STANDARD_DEVIATION 13.79 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Double-blind Baseline Chronic Lower Back Pain (CLBP) Intensity VAS
|
NA scores on a scale
STANDARD_DEVIATION NA • n=5 Participants
|
26.9 scores on a scale
STANDARD_DEVIATION 13.78 • n=7 Participants
|
31.7 scores on a scale
STANDARD_DEVIATION 11.17 • n=5 Participants
|
28.5 scores on a scale
STANDARD_DEVIATION 13.14 • n=4 Participants
|
|
Double-blind Participant's Global Assessment of Back Pain Status
Fair
|
NA participants
n=5 Participants
|
21 participants
n=7 Participants
|
14 participants
n=5 Participants
|
NA participants
n=4 Participants
|
|
Double-blind Participant's Global Assessment of Back Pain Status
Good
|
NA participants
n=5 Participants
|
57 participants
n=7 Participants
|
29 participants
n=5 Participants
|
NA participants
n=4 Participants
|
|
Double-blind Participant's Global Assessment of Back Pain Status
Poor
|
NA participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
NA participants
n=4 Participants
|
|
Double-blind Participant's Global Assessment of Back Pain Status
Very Good
|
NA participants
n=5 Participants
|
15 participants
n=7 Participants
|
3 participants
n=5 Participants
|
NA participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Double-blind baseline to Day 29Population: The analysis of the primary outcome measure included all randomized participants who received at least 1 dose of study drug during the double-blind period (double-blind intent-to-treat) and had at least 1 assessment during the double-blind period.
The change from the double-blind randomization baseline (DB baseline: the last assessment before first dose in the double-blind period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from an ANCOVA model.
Outcome measures
| Measure |
Double-blind Hydrocodone/Acetaminophen Extended Release
n=95 Participants
1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks.
|
Double-blind Placebo
n=46 Participants
1 placebo tablet, twice daily, for 2 weeks.
|
|---|---|---|
|
Change From Double-blind Baseline in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)
|
10.9 scores on a scale
Standard Error 2.86
|
19.9 scores on a scale
Standard Error 3.77
|
SECONDARY outcome
Timeframe: Double-blind baseline to Day 29The participant's overall impression of their back pain status was obtained by having the participant answer the question "Considering all the ways your chronic low back pain affects you, how are you doing today?" on a 5-point categorical scale: very good (no symptoms and no limitation of normal activities); good (mild symptoms and no limitation of normal activities); fair (moderate symptoms and limitation of some normal activities); poor (severe symptoms and inability to carry out most normal activities); very poor (very severe symptoms which are intolerable and inability to carry out all normal activities).
Outcome measures
| Measure |
Double-blind Hydrocodone/Acetaminophen Extended Release
n=95 Participants
1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks.
|
Double-blind Placebo
n=46 Participants
1 placebo tablet, twice daily, for 2 weeks.
|
|---|---|---|
|
Participant's Global Assessment of Back Pain Status at Final Evaluation
Very Good
|
13 participants
|
2 participants
|
|
Participant's Global Assessment of Back Pain Status at Final Evaluation
Good
|
47 participants
|
16 participants
|
|
Participant's Global Assessment of Back Pain Status at Final Evaluation
Fair
|
25 participants
|
19 participants
|
|
Participant's Global Assessment of Back Pain Status at Final Evaluation
Poor
|
10 participants
|
9 participants
|
|
Participant's Global Assessment of Back Pain Status at Final Evaluation
Very Poor
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Double-blind baseline to Day 29Population: Double-blind intent to treat population; scores for participants with no post-randomization assessment were excluded from this analysis.
The participant's overall impression of the study drug was obtained by having the participant answer the question "How would you rate your overall response to the study medication?" on a 5-point categorical scale: excellent; very good; good; fair; poor.
Outcome measures
| Measure |
Double-blind Hydrocodone/Acetaminophen Extended Release
n=93 Participants
1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks.
|
Double-blind Placebo
n=46 Participants
1 placebo tablet, twice daily, for 2 weeks.
|
|---|---|---|
|
Participant's Global Assessment of Study Drug at Final Evaluation
Poor
|
13 participants
|
5 participants
|
|
Participant's Global Assessment of Study Drug at Final Evaluation
Excellent
|
2 participants
|
7 participants
|
|
Participant's Global Assessment of Study Drug at Final Evaluation
Very Good
|
11 participants
|
4 participants
|
|
Participant's Global Assessment of Study Drug at Final Evaluation
Good
|
36 participants
|
19 participants
|
|
Participant's Global Assessment of Study Drug at Final Evaluation
Fair
|
31 participants
|
11 participants
|
Adverse Events
Open-label Hydrocodone/Acetaminophen Extended Release
Serious events: 0 serious events
Other events: 70 other events
Deaths: 0 deaths
Double-blind Hydrocodone/Acetaminophen Extended Release
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Double-blind Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open-label Hydrocodone/Acetaminophen Extended Release
n=168 participants at risk
2 hydrocodone/acetaminophen extended release tablets, twice daily, for 2 weeks. These participants enrolled in the study and received at least one dose of study drug during the open-label period.
|
Double-blind Hydrocodone/Acetaminophen Extended Release
n=99 participants at risk
1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive hydrocodone/acetaminophen extended release during the double-blind period.
|
Double-blind Placebo
n=47 participants at risk
1 placebo tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive placebo during the double-blind period.
|
|---|---|---|---|
|
General disorders
CHEST PAIN
|
0.00%
0/168 • AEs were recorded from the time of study drug administration to 30 days after last dose (total 9 weeks); SAEs were recorded from the time that informed consent was obtained until 30 days following discontinuation of study drug (total 13 weeks).
AEs with onset during the OL period are shown separately from AEs with onset after the first dose of study drug (hydrocodone/acetaminophen extended release or placebo) in the DB period.
|
0.00%
0/99 • AEs were recorded from the time of study drug administration to 30 days after last dose (total 9 weeks); SAEs were recorded from the time that informed consent was obtained until 30 days following discontinuation of study drug (total 13 weeks).
AEs with onset during the OL period are shown separately from AEs with onset after the first dose of study drug (hydrocodone/acetaminophen extended release or placebo) in the DB period.
|
2.1%
1/47 • AEs were recorded from the time of study drug administration to 30 days after last dose (total 9 weeks); SAEs were recorded from the time that informed consent was obtained until 30 days following discontinuation of study drug (total 13 weeks).
AEs with onset during the OL period are shown separately from AEs with onset after the first dose of study drug (hydrocodone/acetaminophen extended release or placebo) in the DB period.
|
Other adverse events
| Measure |
Open-label Hydrocodone/Acetaminophen Extended Release
n=168 participants at risk
2 hydrocodone/acetaminophen extended release tablets, twice daily, for 2 weeks. These participants enrolled in the study and received at least one dose of study drug during the open-label period.
|
Double-blind Hydrocodone/Acetaminophen Extended Release
n=99 participants at risk
1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive hydrocodone/acetaminophen extended release during the double-blind period.
|
Double-blind Placebo
n=47 participants at risk
1 placebo tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive placebo during the double-blind period.
|
|---|---|---|---|
|
Nervous system disorders
HEADACHE
|
5.4%
9/168 • AEs were recorded from the time of study drug administration to 30 days after last dose (total 9 weeks); SAEs were recorded from the time that informed consent was obtained until 30 days following discontinuation of study drug (total 13 weeks).
AEs with onset during the OL period are shown separately from AEs with onset after the first dose of study drug (hydrocodone/acetaminophen extended release or placebo) in the DB period.
|
1.0%
1/99 • AEs were recorded from the time of study drug administration to 30 days after last dose (total 9 weeks); SAEs were recorded from the time that informed consent was obtained until 30 days following discontinuation of study drug (total 13 weeks).
AEs with onset during the OL period are shown separately from AEs with onset after the first dose of study drug (hydrocodone/acetaminophen extended release or placebo) in the DB period.
|
6.4%
3/47 • AEs were recorded from the time of study drug administration to 30 days after last dose (total 9 weeks); SAEs were recorded from the time that informed consent was obtained until 30 days following discontinuation of study drug (total 13 weeks).
AEs with onset during the OL period are shown separately from AEs with onset after the first dose of study drug (hydrocodone/acetaminophen extended release or placebo) in the DB period.
|
|
Gastrointestinal disorders
CONSTIPATION
|
19.0%
32/168 • AEs were recorded from the time of study drug administration to 30 days after last dose (total 9 weeks); SAEs were recorded from the time that informed consent was obtained until 30 days following discontinuation of study drug (total 13 weeks).
AEs with onset during the OL period are shown separately from AEs with onset after the first dose of study drug (hydrocodone/acetaminophen extended release or placebo) in the DB period.
|
3.0%
3/99 • AEs were recorded from the time of study drug administration to 30 days after last dose (total 9 weeks); SAEs were recorded from the time that informed consent was obtained until 30 days following discontinuation of study drug (total 13 weeks).
AEs with onset during the OL period are shown separately from AEs with onset after the first dose of study drug (hydrocodone/acetaminophen extended release or placebo) in the DB period.
|
4.3%
2/47 • AEs were recorded from the time of study drug administration to 30 days after last dose (total 9 weeks); SAEs were recorded from the time that informed consent was obtained until 30 days following discontinuation of study drug (total 13 weeks).
AEs with onset during the OL period are shown separately from AEs with onset after the first dose of study drug (hydrocodone/acetaminophen extended release or placebo) in the DB period.
|
|
Gastrointestinal disorders
NAUSEA
|
13.1%
22/168 • AEs were recorded from the time of study drug administration to 30 days after last dose (total 9 weeks); SAEs were recorded from the time that informed consent was obtained until 30 days following discontinuation of study drug (total 13 weeks).
AEs with onset during the OL period are shown separately from AEs with onset after the first dose of study drug (hydrocodone/acetaminophen extended release or placebo) in the DB period.
|
2.0%
2/99 • AEs were recorded from the time of study drug administration to 30 days after last dose (total 9 weeks); SAEs were recorded from the time that informed consent was obtained until 30 days following discontinuation of study drug (total 13 weeks).
AEs with onset during the OL period are shown separately from AEs with onset after the first dose of study drug (hydrocodone/acetaminophen extended release or placebo) in the DB period.
|
8.5%
4/47 • AEs were recorded from the time of study drug administration to 30 days after last dose (total 9 weeks); SAEs were recorded from the time that informed consent was obtained until 30 days following discontinuation of study drug (total 13 weeks).
AEs with onset during the OL period are shown separately from AEs with onset after the first dose of study drug (hydrocodone/acetaminophen extended release or placebo) in the DB period.
|
|
Nervous system disorders
DIZZINESS
|
10.7%
18/168 • AEs were recorded from the time of study drug administration to 30 days after last dose (total 9 weeks); SAEs were recorded from the time that informed consent was obtained until 30 days following discontinuation of study drug (total 13 weeks).
AEs with onset during the OL period are shown separately from AEs with onset after the first dose of study drug (hydrocodone/acetaminophen extended release or placebo) in the DB period.
|
0.00%
0/99 • AEs were recorded from the time of study drug administration to 30 days after last dose (total 9 weeks); SAEs were recorded from the time that informed consent was obtained until 30 days following discontinuation of study drug (total 13 weeks).
AEs with onset during the OL period are shown separately from AEs with onset after the first dose of study drug (hydrocodone/acetaminophen extended release or placebo) in the DB period.
|
2.1%
1/47 • AEs were recorded from the time of study drug administration to 30 days after last dose (total 9 weeks); SAEs were recorded from the time that informed consent was obtained until 30 days following discontinuation of study drug (total 13 weeks).
AEs with onset during the OL period are shown separately from AEs with onset after the first dose of study drug (hydrocodone/acetaminophen extended release or placebo) in the DB period.
|
|
Nervous system disorders
SOMNOLENCE
|
7.7%
13/168 • AEs were recorded from the time of study drug administration to 30 days after last dose (total 9 weeks); SAEs were recorded from the time that informed consent was obtained until 30 days following discontinuation of study drug (total 13 weeks).
AEs with onset during the OL period are shown separately from AEs with onset after the first dose of study drug (hydrocodone/acetaminophen extended release or placebo) in the DB period.
|
1.0%
1/99 • AEs were recorded from the time of study drug administration to 30 days after last dose (total 9 weeks); SAEs were recorded from the time that informed consent was obtained until 30 days following discontinuation of study drug (total 13 weeks).
AEs with onset during the OL period are shown separately from AEs with onset after the first dose of study drug (hydrocodone/acetaminophen extended release or placebo) in the DB period.
|
0.00%
0/47 • AEs were recorded from the time of study drug administration to 30 days after last dose (total 9 weeks); SAEs were recorded from the time that informed consent was obtained until 30 days following discontinuation of study drug (total 13 weeks).
AEs with onset during the OL period are shown separately from AEs with onset after the first dose of study drug (hydrocodone/acetaminophen extended release or placebo) in the DB period.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
6.5%
11/168 • AEs were recorded from the time of study drug administration to 30 days after last dose (total 9 weeks); SAEs were recorded from the time that informed consent was obtained until 30 days following discontinuation of study drug (total 13 weeks).
AEs with onset during the OL period are shown separately from AEs with onset after the first dose of study drug (hydrocodone/acetaminophen extended release or placebo) in the DB period.
|
0.00%
0/99 • AEs were recorded from the time of study drug administration to 30 days after last dose (total 9 weeks); SAEs were recorded from the time that informed consent was obtained until 30 days following discontinuation of study drug (total 13 weeks).
AEs with onset during the OL period are shown separately from AEs with onset after the first dose of study drug (hydrocodone/acetaminophen extended release or placebo) in the DB period.
|
0.00%
0/47 • AEs were recorded from the time of study drug administration to 30 days after last dose (total 9 weeks); SAEs were recorded from the time that informed consent was obtained until 30 days following discontinuation of study drug (total 13 weeks).
AEs with onset during the OL period are shown separately from AEs with onset after the first dose of study drug (hydrocodone/acetaminophen extended release or placebo) in the DB period.
|
Additional Information
Global Medical Services
AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER