Trial · NCT01400139
Long-term Safety of Once-daily Hydrocodone Bitartrate (HYD) Tablets For Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain. Includes a 24-week Extension Period.
NCT01400139, Phase 3, Completed, Purdue Pharma LP; results first posted 2014-12-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-term Safety of Once-daily Hydrocodone Bitartrate (HYD) Tablets For Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain. Includes a 24-week Extension Period. Trials, record NCT01400139. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01400139
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Safety of Once-daily Hydrocodone Bitartrate (HYD) Tablets For Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain. Includes a 24-week Extension Period.
- NCT number
- NCT01400139
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 922 participants, actual
- Lead sponsor
- Purdue Pharma LP
- Conditions
- Chronic Nonmalignant and Nonneuropathic Pain
- Interventions
- Hydrocodone bitartrate q24h film-coated tablets
- First posted
- 2011-07-22
- Last updated
- 2020-03-10
- Results first posted
- 2014-12-04
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Participants With Adverse Events as a Measure of Safety | Up to 84 weeks | Safety assessments included AEs, clinical laboratory test results, vital sign measurements, ECG findings, and audiology assessments. |
| Primary | Daily "Average Pain Over the Last 24 Hours" | Core study: from start to end of maintenance period (up to 52 weeks); Extension study: from start of maintenance to end of extension (up to 76 weeks) | "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). |
| Secondary | "Pain Right Now" Score | Week 12 | "Pain right now" scores were collected using an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. The "pain right now" scores were only collected during the Core Study. "Pain right now" scores were not assessed during the Extension Period. |
| Secondary | Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R) | Baseline and up to 52 weeks in the Core Study maintenance period, and up to 24 weeks in the Extension Period | 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 II and 6 subscale scores - sleep disturbance, sleep adequacy, daytime somnolence, snoring, awaken short of breath or with headache, and quantity of sleep. For each individual and time of assessment, quantity of sleep was recorded as the number of hours slept per night. The number of hours it took the subject to fall asleep per night was categorized 1, 2, 3, 4, or 5 corresponding to 0 through 15, 16 through 30, 31 through 45, 46 through 60, or more than 60 minutes, respectively. The other scales were recorded as 1 = all of the time, 2 = most of the time, 3 = some of the time, 4 = a little of the time, or 5 = none of the time. A higher value indicates a better score, therefore a positive change from baseline indicates a better sleep pattern and a negative change from baseline indicates a worsening in sleep pattern. |
| Secondary | Brief Pain Inventory Short Form (BPI-SF) | Up to 52 weeks in the Core Study maintenance period, and up to 24 weeks in the Extension Period | The BPI-SF assessed the severity of pain and interference of pain on daily functions. It consists of 9 sections denoted by Q1 to Q8 and Q9A to Q9G according to their order in the questionnaire, that measure pain location, intensity, pain treatment, and functional interference of pain on mood and every day activities. Scores ranged from 0 (none) to 10 (worst as can be). Four of the items (questions 3 to 6) assess severity of pain and 7 items (questions 9A to 9G) assess interference of pain. The pain interference subscale score was determined by calculating the mean of responses to Q9A - Q9G \[Q9A (general activity), Q9B (mood),Q9C (walking), Q9D (working), Q9E (relations with others), Q9F (sleep), and Q9G (enjoyment of life)\] and the severity of pain subscale score was determined by calculating the mean of responses to Q3 - Q6 \[Q3 (worst pain in last 24 hours), Q4 (least pain in last 24 hours), Q5 (average pain), and Q6 ("pain right now")\]. A lower score indicates lower pain. |
| Secondary | Medical Outcomes Study 36-item Short Form (SF-36) | Up to 52 weeks in the Core Study maintenance period, and up to 24 weeks in the Extension Period | The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The 36 questions are grouped into 11 sections. Some of the sections consist of multiple questions. The survey is summarized into 8 dimensions/scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. From the 8 health dimensions, physical component summary, and mental component summary measures are derived. Scores on each scale ranged from 0 to 100; a higher score indicates a better perception of health. |
| Secondary | Patient Global Impression of Change (PGIC) | At Week 52 in the Core Study maintenance period and at Week 24 in the Extension Period | The PGIC is an ordinal scale of global evaluation that assesses the change in overall status relative to the start of the study. The scale has only 1 item that measures global change of overall status (improvement or worsening) by the subject on a 7-point scale (Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. |
| Secondary | Treatment Satisfaction Questionnaire (TSQ) - Part I | At Week 52 or upon early discontinuation at or before Week 4 in the Core Study maintenance period | The TSQ is a self-administered questionnaire that consists of 2 parts. Part I has 6 questions (Q1 to Q6) that ask the subject to rate the experience with use of the study drug in comparison to the prestudy pain medication regarding ease of use, convenience, frequency, pain control, and overall satisfaction. Each question was rated on a scale from 1 (extremely satisfied) to 6 (extremely dissatisfied): Q1=Satisfaction with study drug; Q2=Ease of study drug use to treat pain; Q3=Convenience of study drug to treat pain; Q4=Overall drug satisfaction managing pain; Q5=Satisfaction with frequency of use; Q6=Ease of planning study drug use. The number of subjects with each category (1-6) of response for each individual question (Q1-Q6) was summarized for subjects who entered the core study maintenance period and responded to each question. TSQ - Part I was not administered in the extension period. |
| Secondary | Treatment Satisfaction Questionnaire (TSQ) - Part II | At Week 52 or upon early discontinuation at or before Week 4 in maintenance and at Week 24 in extension | The TSQ is a self-administered questionnaire that consists of 2 parts. Part II has 2 questions that measure the subject's willingness to continue the use of study drug as pain medication (Q1), and to recommend the study drug to someone else (Q2). Question 1 consists of 6 categories of response rated on a scale from 1 (very willing to continue) to 6 (very unwilling to continue): 1=Very willing to continue; 2=Willing to continue; 3=Somewhat willing to continue; 4=Somewhat unwilling to continue; 5=Unwilling to continue; 6=Very unwilling to continue. Question 2 consists of 3 categories of response: 1=yes; 2=no; 3=undecided. The number of subjects with each category of response for each individual question was summarized for subjects completing the core study maintenance period and for those enrolled in the extension period. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number of Participants With Adverse Events as a Measure of Safety | Up to 84 weeks | The Core Study safety population (N=922) was defined as the group of subjects who received at least 1 dose of study drug during the study. The Extension Period safety population (N=106) was the group of core study safety population subjects who entered the extension period and received at least 1 dose of study drug in the extension period. | participants | NUMBER |
| PRIMARY | Daily Average Pain Over the Last 24 Hours | Core study: from start to end of maintenance period (up to 52 weeks); Extension study: from start of maintenance to end of extension (up to 76 weeks) | The Core Study population analyzed (N=727) was the group of subjects who received at least 1 dose of study drug during the maintenance period. The Extension Period population analyzed (N=106) was the group of core study safety population subjects who entered the extension period and received at least 1 dose of study drug in the extension period. | units on a scale | MEAN |
| SECONDARY | Pain Right Now Score | Week 12 | The Core Study population analyzed was the group of subjects who received at least 1 dose of study drug during the maintenance period and provided data. Data were not collected for this outcome measure during the Extension Period. | units on a scale | MEAN |
| SECONDARY | Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R) | Baseline and up to 52 weeks in the Core Study maintenance period, and up to 24 weeks in the Extension Period | The Core Study population analyzed was the group of subjects who received at least 1 dose of study drug during the maintenance period and provided data. The Extension Period safety population was the group of core study safety population subjects who entered the extension and received at least 1 dose of study drug in the extension period. | units on a scale | MEAN |
| SECONDARY | Brief Pain Inventory Short Form (BPI-SF) | Up to 52 weeks in the Core Study maintenance period, and up to 24 weeks in the Extension Period | The Core Study population analyzed was the group of subjects who received at least 1 dose of study drug during the maintenance period and provided data. The Extension Period safety population was the group of core study safety population subjects who entered the extension and received at least 1 dose of study drug in the extension period. | units on a scale | MEAN |
| SECONDARY | Medical Outcomes Study 36-item Short Form (SF-36) | Up to 52 weeks in the Core Study maintenance period, and up to 24 weeks in the Extension Period | The Core Study population analyzed was the group of subjects who received at least 1 dose of study drug during the maintenance period and provided data. The Extension Period safety population was the group of core study safety population subjects who entered the extension period and received at least 1 dose of study drug in the extension period. | units on a scale | MEAN |
| SECONDARY | Patient Global Impression of Change (PGIC) | At Week 52 in the Core Study maintenance period and at Week 24 in the Extension Period | The Core Study population analyzed was the group of subjects who received at least 1 dose of study drug during the study. The Extension Period safety population was the group of core study safety population subjects who entered the extension period and received at least 1 dose of study drug in the extension period. | participants | NUMBER |
| SECONDARY | Treatment Satisfaction Questionnaire (TSQ) - Part I | At Week 52 or upon early discontinuation at or before Week 4 in the Core Study maintenance period | The Core Study population analyzed was the group of subjects who received at least 1 dose of study drug during the maintenance period and provided data. | participants | NUMBER |
| SECONDARY | Treatment Satisfaction Questionnaire (TSQ) - Part II | At Week 52 or upon early discontinuation at or before Week 4 in maintenance and at Week 24 in extension | The Core Study population analyzed was the group of subjects who received at least 1 dose of study drug during the maintenance period and provided data. The Extension Period safety population was the group of core study safety population subjects who entered the extension period and received at least 1 dose of study drug in the extension period. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group135
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Participants With Adverse Events as a Measure of Safety | HYD Core Study | Serious adverse events | 80 | participants | |
| The Number of Participants With Adverse Events as a Measure of Safety | HYD Extension Period | Serious adverse events | 6 | participants | |
| The Number of Participants With Adverse Events as a Measure of Safety | HYD Core Study | All other adverse events in ≥ 5% of patients | 586 | participants | |
| The Number of Participants With Adverse Events as a Measure of Safety | HYD Extension Period | All other adverse events in ≥ 5% of patients | 0 | participants | |
| Daily Average Pain Over the Last 24 Hours | HYD Core Study | 3.6 | Standard Deviation 1.80 | units on a scale | |
| Daily Average Pain Over the Last 24 Hours | HYD Extension Period | 3.8 | Standard Deviation 1.73 | units on a scale | |
| Pain Right Now Score | HYD Core Study | 3.46 | Standard Error 0.071 | units on a scale | |
| Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R) | HYD Core Study | Change from Baseline in Sleep Disturbance | 4.69 | Standard Deviation 8.276 | units on a scale |
| Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R) | HYD Extension Period | Change from Baseline in Sleep Disturbance | 3.65 | Standard Deviation 7.993 | units on a scale |
| Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R) | HYD Core Study | Change from Baseline in Sleep Adequacy | 3.29 | Standard Deviation 8.959 | units on a scale |
1 to 10 of 135Source ClinicalTrials.gov
See all 135 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| HYD Core Study | STARTED | Hydrocodone Bitartrate (HYD) | 922 | |
| HYD Core Study | COMPLETED | Hydrocodone Bitartrate (HYD) | 410 | |
| HYD Core Study | NOT COMPLETED | Hydrocodone Bitartrate (HYD) | 512 | |
| HYD Extension Period | STARTED | Hydrocodone Bitartrate (HYD) | 106 | |
| HYD Extension Period | COMPLETED | Hydrocodone Bitartrate (HYD) | 83 | |
| HYD Extension Period | NOT COMPLETED | Hydrocodone Bitartrate (HYD) | 23 |
Source ClinicalTrials.gov
Adverse events230
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 | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | HYD Core Study | 218 | 922 | |
| other | Nausea | Gastrointestinal disorders | HYD Extension Period | 0 | 106 | |
| other | Constipation | Gastrointestinal disorders | HYD Core Study | 193 | 922 | |
| other | Constipation | Gastrointestinal disorders | HYD Extension Period | 0 | 106 | |
| other | Vomiting | Gastrointestinal disorders | HYD Core Study | 100 | 922 | |
| other | Vomiting | Gastrointestinal disorders | HYD Extension Period | 0 | 106 | |
| other | Diarrhoea | Gastrointestinal disorders | HYD Core Study | 56 | 922 | |
| other | Diarrhoea | Gastrointestinal disorders | HYD Extension Period | 0 | 106 | |
| other | Fatigue | General disorders | HYD Core Study | 71 | 922 | |
| other | Fatigue | General disorders | HYD Extension Period | 0 | 106 |
1 to 10 of 230Source ClinicalTrials.gov
See all 230 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HYD Core Study | ||
| Total, all-cause mortality | HYD Extension Period | ||
| Total, other adverse events | HYD Core Study | 586 | 922 |
| Total, other adverse events | HYD Extension Period | 0 | 106 |
| Total, serious adverse events | HYD Core Study | 80 | 922 |
| Total, serious adverse events | HYD Extension Period | 6 | 106 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| HYD Core Study vs HYD Extension Period: serious adverse events |
Source Trial comparisons
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.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01400139
GET https://conductscience.org/api/trials/v1/NCT01400139/results?page=2