Trial · NCT01115569
Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain
NCT01115569, Phase 3, Completed, Zogenix, Inc.; results first posted 2014-04-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain. Trials, record NCT01115569. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01115569
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain
- NCT number
- NCT01115569
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 424 participants, actual
- Lead sponsor
- Zogenix, Inc.
- Conditions
- Chronic Pain
- Interventions
- Hydrocodone Bitartrate
- First posted
- 2010-05-04
- Last updated
- 2022-11-09
- Results first posted
- 2014-04-25
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Average Daily Pain | 1 year | Numeric Rating Scale (NRS) for Pain (0-10; where 0 = no pain, 10 = worst pain imaginable) recorded up to 54 weeks, starting at screening through end of study. Lower number equals better outcome. |
| Secondary | Maintenance of Efficacy | 1 year | Clinic Numeric Rating Scale (NRS), Brief Pain Inventory (BPI), Oswestry Disability Index, Hospital Anxiety and Depression Scale, Rescue Doses and Subject Global of Medication |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in Average Daily Pain | 1 year | The number of participants for analysis was determined by the safety population. Numeric Rating Scale (NRS) for Pain assessment was used. Measure is mean change in average daily pain intensity. Total number of participants providing end of study pain intensity score = 391. | units on a scale | MEAN |
| SECONDARY | Maintenance of Efficacy | 1 year |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in Average Daily Pain | Open-label Hydrocodone Bitartrate Extended Release Capsules | 0.921 | Standard Deviation 2.2 | units on a scale |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Conversion/Titration Phase | STARTED | Open-label Hydrocodone Bitartrate Extended Release (HC-ER) | 638 | |
| Conversion/Titration Phase | STARTED | Open-label Hydrocodone Bitartrate Extended Release Capsules | 0 | |
| Conversion/Titration Phase | COMPLETED | Open-label Hydrocodone Bitartrate Extended Release (HC-ER) | 424 | |
| Conversion/Titration Phase | COMPLETED | Open-label Hydrocodone Bitartrate Extended Release Capsules | 0 | |
| Conversion/Titration Phase | NOT COMPLETED | Open-label Hydrocodone Bitartrate Extended Release (HC-ER) | 214 | |
| Conversion/Titration Phase | NOT COMPLETED | Open-label Hydrocodone Bitartrate Extended Release Capsules | 0 | |
| Maintenance Phase | STARTED | Open-label Hydrocodone Bitartrate Extended Release (HC-ER) | 0 | |
| Maintenance Phase | STARTED | Open-label Hydrocodone Bitartrate Extended Release Capsules | 424 | |
| Maintenance Phase | COMPLETED | Open-label Hydrocodone Bitartrate Extended Release (HC-ER) | 0 | |
| Maintenance Phase | COMPLETED | Open-label Hydrocodone Bitartrate Extended Release Capsules | 285 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events220
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 | Constipation | Gastrointestinal disorders | Conversion/Titration Phase | 72 | 638 | |
| other | Constipation | Gastrointestinal disorders | Maintenance Treatment Phase | 53 | 424 | |
| other | Nausea | Gastrointestinal disorders | Conversion/Titration Phase | 68 | 638 | |
| other | Nausea | Gastrointestinal disorders | Maintenance Treatment Phase | 42 | 424 | |
| other | Somnolence | Nervous system disorders | Conversion/Titration Phase | 49 | 638 | |
| other | Somnolence | Nervous system disorders | Maintenance Treatment Phase | 18 | 424 | |
| other | Headache | Nervous system disorders | Conversion/Titration Phase | 48 | 638 | |
| other | Headache | Nervous system disorders | Maintenance Treatment Phase | 29 | 424 | |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Conversion/Titration Phase | 9 | 638 | |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Maintenance Treatment Phase | 47 | 424 |
1 to 10 of 220Source ClinicalTrials.gov
See all 220 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Conversion/Titration Phase | ||
| Total, all-cause mortality | Maintenance Treatment Phase | ||
| Total, other adverse events | Conversion/Titration Phase | 277 | 638 |
| Total, other adverse events | Maintenance Treatment Phase | 298 | 424 |
| Total, serious adverse events | Conversion/Titration Phase | 26 | 638 |
| Total, serious adverse events | Maintenance Treatment Phase | 73 | 424 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|
| Conversion/Titration Phase vs Maintenance Treatment Phase: 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/NCT01115569
GET https://conductscience.org/api/trials/v1/NCT01115569/events?page=2