A Phase 3 interventional study of Hydrocodone bitartrate q24h film-coated tablets and Placebo to match hydrocodone bitartrate q24h tablets in Chronic Low Back Pain, sponsored by Purdue Pharma LP. Completed at 102 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-10.
Sponsored by Purdue Pharma LP (part of Knoa Pharma) · Phase 3, Interventional, and Treatment
The primary objective of this study is to evaluate the analgesic efficacy and safety of HYD tablets 20 to 120 mg once-daily dose compared to placebo in subjects with moderate to severe chronic low back pain uncontrolled by their current stable analgesic regimen
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 905 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Purdue Pharma LP is the lead sponsor of 58 studies on the registry; none are open to participants now.
First submitted before Purdue Pharma LP became part of Knoa Pharma.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria include:
Other protocol-specific inclusion/exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hydrocodone bitartrate (HYD) once daily (q24h) tablets
Drug: Hydrocodone bitartrate q24h film-coated tablets
Placebo to match hydrocodone bitartrate once daily tablets
Drug: Placebo to match hydrocodone bitartrate q24h tablets
Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily
Also known as: Hysingla ER
Placebo to match hydrocodone bitartrate q24h film coated tablets 20 - 120 mg once daily
Mean Pain Intensity for "Average Pain Over the Last 24 Hours" Score
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
Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) - Sleep Disturbance Subscale
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
Patient Global Impression of Change (PGIC)
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
Responder Analysis for Subjects With a ≥ 30% Reduction in Pain Compared to Baseline
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
Responder Analysis for Subjects With a ≥ 50% Reduction in Pain Compared to Baseline
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
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.
| Milestone | Open-label Run-in Dose-titration Period Hydrocodone Bitartrate | Hydrocodone Bitartrate | Placebo |
|---|---|---|---|
| Started | 905 | 0 | 0 |
| Completed | 592 | 0 | 0 |
| Not completed | 313 | 0 | 0 |
| Withdrew: Adverse event | 96 | 0 | 0 |
| Withdrew: Withdrawal by subject | 49 | 0 | 0 |
| Withdrew: Lost to follow-up | 19 | 0 | 0 |
| Withdrew: Lack of efficacy | 46 | 0 | 0 |
| Withdrew: Confirmed or suspected diversion | 23 | 0 | 0 |
| Withdrew: Administrative | 21 | 0 | 0 |
| Withdrew: Did not qualify for double-blind phase | 59 | 0 | 0 |
| Milestone | Open-label Run-in Dose-titration Period Hydrocodone Bitartrate | Hydrocodone Bitartrate | Placebo |
|---|---|---|---|
| Started | 0 | 296 | 292 |
| Completed | 0 | 229 | 210 |
| Not completed | 0 | 67 | 82 |
| Withdrew: Adverse event | 0 | 18 | 11 |
| Withdrew: Withdrawal by subject | 0 | 15 | 14 |
| Withdrew: Lost to follow-up | 0 | 5 | 3 |
| Withdrew: Lack of efficacy | 0 | 16 | 44 |
| Withdrew: Confirmed or suspected diversion | 0 | 2 | 3 |
| Withdrew: Administrative | 0 | 11 | 7 |
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).
| units on a scale | Hydrocodone Bitartrate | Placebo |
|---|---|---|
| Mean Pain Intensity for "Average Pain Over the Last 24 Hours" Score | 3.7 ± 0.13 | 4.2 ± 0.13 |
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.
| units on a scale | Hydrocodone Bitartrate | Placebo |
|---|---|---|
| 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 |
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.
| Participants | Hydrocodone Bitartrate | Placebo |
|---|---|---|
| Total Subjects Completing PGIC | 283 | 267 |
| Subjects Responding Very Much or Much Improved | 173 | 130 |
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.
| Participants | Hydrocodone Bitartrate | Placebo |
|---|---|---|
| Number of Subjects Responding | 285 | 280 |
| Number of Subjects with ≥ 30% Reduction in Pain | 184 | 147 |
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.
| Participants | Hydrocodone Bitartrate | Placebo |
|---|---|---|
| Number of Subjects Responding | 285 | 280 |
| Number of Subjects with ≥ 50% Reduction in Pain | 137 | 109 |
Collected over Adverse events (AEs) were reported from start of study participation through the period beyond study completion.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Open-label Run-in Dose-titration Period Hydrocodone Bitartrate | — | 7/905 (0.8%) | 265/905 (29.3%) |
| Hydrocodone Bitartrate | — | 2/296 (0.7%) | 52/296 (17.6%) |
| Placebo | — | 4/292 (1.4%) | 30/292 (10.3%) |
| Event | Open-label Run-in Dose-titration Period Hydrocodone Bitartrate | Hydrocodone Bitartrate | Placebo |
|---|---|---|---|
| Atrial fibrillationCardiac disorders | 0/905 | 0/296 | 1/292 |
| CholecystitisHepatobiliary disorders | 0/905 | 0/296 | 1/292 |
| Lobar pneumoniaInfections and infestations | 0/905 | 0/296 | 1/292 |
| ConcussionInjury, poisoning and procedural complications | 0/905 | 0/296 | 1/292 |
| Musculoskeletal chest painMusculoskeletal and connective tissue disorders | 0/905 | 0/296 | 1/292 |
| Squamous cell carcinoma of lungNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/905 | 0/296 | 1/292 |
| EmphysemaRespiratory, thoracic and mediastinal disorders | 0/905 | 0/296 | 1/292 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 0/905 | 0/296 | 1/292 |
| HypothyroidismEndocrine disorders | 0/905 | 1/296 | 0/292 |
| Chest painGeneral disorders | 0/905 | 1/296 | 0/292 |
| Event | Open-label Run-in Dose-titration Period Hydrocodone Bitartrate | Hydrocodone Bitartrate | Placebo |
|---|---|---|---|
| NauseaGastrointestinal disorders | 144/905 | 24/296 | 16/292 |
| ConstipationGastrointestinal disorders | 85/905 | 10/296 | 7/292 |
| VomitingGastrointestinal disorders | 65/905 | 18/296 | 9/292 |
| DizzinessNervous system disorders | 64/905 | 9/296 | 5/292 |
| HeadacheNervous system disorders | 59/905 | 6/296 | 5/292 |
| Age, Continuous(years) | Hydrocodone Bitartrate | Placebo | Total |
|---|---|---|---|
| Mean | 49.2 ± 13.51 | 47.9 ± 13.23 | 48.6 ± 13.38 |
| Sex: Female, Male(Participants) | Hydrocodone Bitartrate | Placebo | Total |
|---|---|---|---|
| Female | 172 | 166 | 338 |
| Male | 124 | 126 | 250 |
| Race/Ethnicity, Customized(participants) | Hydrocodone Bitartrate | Placebo | Total |
|---|---|---|---|
| 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(units on a scale) | Hydrocodone Bitartrate | Placebo | Total |
|---|---|---|---|
| Mean | 7.4 ± 1.13 | 7.4 ± 1.19 | 7.4 ± 1.16 |
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The record gives a start of Oct 2011, a primary completion of Sep 2013 and a completion of Oct 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2014, 1 year 3 months after primary completion.
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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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