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Trial record 97 of 10796 for:    Placebo AND once

Efficacy and Safety of Hydrocodone Bitartrate (HYD) in Subjects With Moderate to Severe Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT01452529
Recruitment Status : Completed
First Posted : October 17, 2011
Results First Posted : December 4, 2014
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Low Back Pain
Interventions Drug: Hydrocodone bitartrate q24h film-coated tablets
Drug: Placebo to match hydrocodone bitartrate q24h tablets
Enrollment 905
Recruitment Details First subject first visit: 23-March-2012; Last subject last visit: 03-September-2013. The study was conducted at medical/research sites in the United States.
Pre-assignment Details Subjects with moderate to severe chronic low back pain uncontrolled by their current stable analgesic regimen were included.
Arm/Group Title Open-label Run-in Dose-titration Period Hydrocodone Bitartrate Hydrocodone Bitartrate Placebo
Hide Arm/Group Description The open-label run-in dose-titration period was designed to assess subjects qualification for randomization

Hydrocodone bitartrate (HYD) once daily (q24h) tablets

Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily

Placebo to match hydrocodone bitartrate once daily tablets

Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 – 120 mg once daily

Period Title: Run-in Period
Started 905 0 0
Completed 592 0 0
Not Completed 313 0 0
Reason Not Completed
Adverse Event             96             0             0
Withdrawal by Subject             49             0             0
Lost to Follow-up             19             0             0
Lack of Efficacy             46             0             0
Confirmed or suspected diversion             23             0             0
Administrative             21             0             0
Did not qualify for Double-Blind Phase             59             0             0
Period Title: Double-blind (DB) Period
Started 0 296 [1] 292
Completed 0 229 [2] 210
Not Completed 0 67 82
Reason Not Completed
Adverse Event             0             18             11
Withdrawal by Subject             0             15             14
Lost to Follow-up             0             5             3
Lack of Efficacy             0             16             44
Confirmed or suspected diversion             0             2             3
Administrative             0             11             7
[1]
Four subjects were randomized but did not receive DB medication
[2]
4 subjects who did not receive DB medication were still counted as discontinued in the DB period
Arm/Group Title Hydrocodone Bitartrate Placebo Total
Hide Arm/Group Description

Hydrocodone bitartrate (HYD) once daily (q24h) tablets

Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily

Placebo to match hydrocodone bitartrate once daily tablets

Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 – 120 mg once daily

Total of all reporting groups
Overall Number of Baseline Participants 296 292 588
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 296 participants 292 participants 588 participants
49.2  (13.51) 47.9  (13.23) 48.6  (13.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 296 participants 292 participants 588 participants
Female
172
  58.1%
166
  56.8%
338
  57.5%
Male
124
  41.9%
126
  43.2%
250
  42.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 296 participants 292 participants 588 participants
White 195 207 402
Black or African American 67 51 118
Asian 25 29 54
American Indian or Alaska Native 2 1 3
Other 7 4 11
Screening Baseline Pain Over the Last 24 Hours   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 296 participants 292 participants 588 participants
7.4  (1.13) 7.4  (1.19) 7.4  (1.16)
[1]
Measure Description: "Average pain over the last 24 hours" score (on an 11-point numerical rating scale where 0 = no pain and 10 = pain as bad as you can imagine).
1.Primary Outcome
Title Mean Pain Intensity for "Average Pain Over the Last 24 Hours" Score
Hide Description Mean pain intensity for "average pain over the last 24 hours" score (on an 11-point numerical rating scale where 0 = no pain and 10 = pain as bad as you can imagine).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis population (N = 588) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug
Arm/Group Title Hydrocodone Bitartrate Placebo
Hide Arm/Group Description:

Hydrocodone bitartrate (HYD) once daily (q24h) tablets

Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily

Placebo to match hydrocodone bitartrate once daily tablets

Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 – 120 mg once daily

Overall Number of Participants Analyzed 296 292
Mean (Standard Error)
Unit of Measure: units on a scale
3.7  (0.13) 4.2  (0.13)
2.Secondary Outcome
Title Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) - Sleep Disturbance Subscale
Hide Description The MOS Sleep-R is a brief, self-administered 12-item assessment designed to measure key aspects of sleep. It includes a sleep problems index and 6 subscales – sleep disturbance, sleep adequacy, daytime somnolence, snoring, awaken short of breath or with headache, and quantity of sleep. The sleep disturbance subscale comprised the responses to questions 1, 3, 7, and 8 on the assessment. The individual responses for each question were recorded on a 5-point scale with options ranging from 1 - "all of the time" to 5 - "none of the time". Sleep disturbance scores were transformed linearly on a scale of 0-100. A higher value indicates a better score; therefore, a higher score indicates a better sleep pattern.
Time Frame Weeks 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis population (N = 588) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug
Arm/Group Title Hydrocodone Bitartrate Placebo
Hide Arm/Group Description:

Hydrocodone bitartrate (HYD) once daily (q24h) tablets

Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily

Placebo to match hydrocodone bitartrate once daily tablets

Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 – 120 mg once daily

Overall Number of Participants Analyzed 296 292
Mean (Standard Deviation)
Unit of Measure: units on a scale
Screening 44.38  (9.262) 44.72  (9.871)
Week 4 50.38  (8.851) 50.51  (9.156)
Week 8 50.16  (8.879) 51.16  (8.781)
Week 12 51.57  (8.576) 52.12  (8.779)
3.Secondary Outcome
Title Patient Global Impression of Change (PGIC)
Hide Description The PGIC is an ordinal scale which assesses the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse), where 1 = very much improved and 7 = very much worse. The proportion of subjects responding "very much improved" and "much improved" was summarized by treatment group.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis population (N = 588) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug
Arm/Group Title Hydrocodone Bitartrate Placebo
Hide Arm/Group Description:

Hydrocodone bitartrate (HYD) once daily (q24h) tablets

Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily

Placebo to match hydrocodone bitartrate once daily tablets

Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 – 120 mg once daily

Overall Number of Participants Analyzed 296 292
Measure Type: Number
Unit of Measure: Participants
Total Subjects Completing PGIC 283 267
Subjects Responding Very Much or Much Improved 173 130
4.Secondary Outcome
Title Responder Analysis for Subjects With a ≥ 30% Reduction in Pain Compared to Baseline
Hide Description A subject’s response to treatment was defined as the percentage reduction from the screening mean pain score to the mean pain intensity at week 12 of the double-blind period.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis population (N = 588) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug
Arm/Group Title Hydrocodone Bitartrate Placebo
Hide Arm/Group Description:

Hydrocodone bitartrate (HYD) once daily (q24h) tablets

Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily

Placebo to match hydrocodone bitartrate once daily tablets

Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 – 120 mg once daily

Overall Number of Participants Analyzed 296 292
Measure Type: Number
Unit of Measure: Participants
Number of Subjects Responding 285 280
Number of Subjects with ≥ 30% Reduction in Pain 184 147
5.Secondary Outcome
Title Responder Analysis for Subjects With a ≥ 50% Reduction in Pain Compared to Baseline
Hide Description A subject’s response to treatment was defined as the percentage reduction from the screening mean pain score to the mean pain intensity at week 12 of the double-blind period.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis population (N = 588) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug
Arm/Group Title Hydrocodone Bitartrate Placebo
Hide Arm/Group Description:

Hydrocodone bitartrate (HYD) once daily (q24h) tablets

Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily

Placebo to match hydrocodone bitartrate once daily tablets

Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 – 120 mg once daily

Overall Number of Participants Analyzed 296 292
Measure Type: Number
Unit of Measure: Participants
Number of Subjects Responding 285 280
Number of Subjects with ≥ 50% Reduction in Pain 137 109
Time Frame Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
Adverse Event Reporting Description AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
 
Arm/Group Title Open-label Run-in Dose-titration Period Hydrocodone Bitartrate Hydrocodone Bitartrate Placebo
Hide Arm/Group Description The open-label run-in dose-titration period was designed to assess subjects' qualification for randomization

Hydrocodone bitartrate (HYD) once daily (q24h) tablets

Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily

Placebo to match hydrocodone bitartrate once daily tablets

Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 – 120 mg once daily

All-Cause Mortality
Open-label Run-in Dose-titration Period Hydrocodone Bitartrate Hydrocodone Bitartrate Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Open-label Run-in Dose-titration Period Hydrocodone Bitartrate Hydrocodone Bitartrate Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/905 (0.77%)   2/296 (0.68%)   4/292 (1.37%) 
Cardiac disorders       
Angina unstable  1  1/905 (0.11%)  0/296 (0.00%)  0/292 (0.00%) 
Atrial fibrillation  1  0/905 (0.00%)  0/296 (0.00%)  1/292 (0.34%) 
Endocrine disorders       
Hypothyroidism  1  0/905 (0.00%)  1/296 (0.34%)  0/292 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  1/905 (0.11%)  0/296 (0.00%)  0/292 (0.00%) 
Vomiting  1  1/905 (0.11%)  0/296 (0.00%)  0/292 (0.00%) 
General disorders       
Chest pain  1  0/905 (0.00%)  1/296 (0.34%)  0/292 (0.00%) 
Hepatobiliary disorders       
Cholecystitis  1  0/905 (0.00%)  0/296 (0.00%)  1/292 (0.34%) 
Infections and infestations       
Lobar pneumonia  1  0/905 (0.00%)  0/296 (0.00%)  1/292 (0.34%) 
Injury, poisoning and procedural complications       
Concussion  1  0/905 (0.00%)  0/296 (0.00%)  1/292 (0.34%) 
Post procedural haemorrhage  1  1/905 (0.11%)  0/296 (0.00%)  0/292 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthritis  1  1/905 (0.11%)  0/296 (0.00%)  0/292 (0.00%) 
Joint effusion  1  1/905 (0.11%)  0/296 (0.00%)  0/292 (0.00%) 
Musculoskeletal chest pain  1  0/905 (0.00%)  0/296 (0.00%)  1/292 (0.34%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Squamous cell carcinoma of lung  1 [1]  0/905 (0.00%)  0/296 (0.00%)  1/292 (0.34%) 
Nervous system disorders       
Intracranial aneurysm  1 [1]  1/905 (0.11%)  0/296 (0.00%)  0/292 (0.00%) 
Psychiatric disorders       
Drug abuse  1  1/905 (0.11%)  0/296 (0.00%)  0/292 (0.00%) 
Major depression  1  0/905 (0.00%)  1/296 (0.34%)  0/292 (0.00%) 
Reproductive system and breast disorders       
Ovarian cyst ruptured  1  1/905 (0.11%)  0/296 (0.00%)  0/292 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Emphysema  1  0/905 (0.00%)  0/296 (0.00%)  1/292 (0.34%) 
Respiratory failure  1  0/905 (0.00%)  0/296 (0.00%)  1/292 (0.34%) 
Surgical and medical procedures       
Abortion induced  1  1/905 (0.11%)  0/296 (0.00%)  0/292 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
[1]
Outcome: Death
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Open-label Run-in Dose-titration Period Hydrocodone Bitartrate Hydrocodone Bitartrate Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   265/905 (29.28%)   52/296 (17.57%)   30/292 (10.27%) 
Gastrointestinal disorders       
Nausea  1  144/905 (15.91%)  24/296 (8.11%)  16/292 (5.48%) 
Constipation  1  85/905 (9.39%)  10/296 (3.38%)  7/292 (2.40%) 
Vomiting  1  65/905 (7.18%)  18/296 (6.08%)  9/292 (3.08%) 
Nervous system disorders       
Dizziness  1  64/905 (7.07%)  9/296 (3.04%)  5/292 (1.71%) 
Headache  1  59/905 (6.52%)  6/296 (2.03%)  5/292 (1.71%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Clinical Leader
Organization: Purdue Pharma L.P.
Phone: 800-733-1333
Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT01452529     History of Changes
Other Study ID Numbers: HYD3002
First Submitted: October 12, 2011
First Posted: October 17, 2011
Results First Submitted: December 1, 2014
Results First Posted: December 4, 2014
Last Update Posted: June 28, 2018