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| Study Type: | Interventional |
|---|---|
| Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
| Condition: |
Pain |
| Intervention: |
Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER) |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
| Description | |
|---|---|
| ALO-01 | No text entered. |
| ALO-01 | |
|---|---|
| STARTED | 467 |
| COMPLETED | 465 |
| NOT COMPLETED | 2 |
| Withdrawal by Subject | 1 |
| Protocol Violation | 1 |
| ALO-01 | |
|---|---|
| STARTED | 465 |
| COMPLETED | 160 |
| NOT COMPLETED | 305 |
| Adverse Event | 110 |
| Lack of Efficacy | 39 |
| Protocol Violation | 67 |
| Physician Decision | 3 |
| Withdrawal by Subject | 51 |
| Lost to Follow-up | 28 |
| Other | 7 |
Baseline Characteristics
| Description | |
|---|---|
| ALO-01 | No text entered. |
| ALO-01 | |
|---|---|
|
Number of Participants [units: participants] |
465 |
|
Age [units: participants] |
|
| <=18 years | 0 |
| Between 18 and 65 years | 417 |
| >=65 years | 48 |
|
Age [units: years] Mean ± Standard Deviation |
51.7 ± 10.56 |
|
Gender [units: participants] |
|
| Female | 245 |
| Male | 220 |
Outcome Measures
More Information
| 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. | ||||||
The agreement is:
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| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
| Responsible Party: | King Pharmaceuticals Research and Development, Inc. ( Kenneth Sommerville, M.D., FAAN, Vice President, Clinical Development ) |
| Study ID Numbers: | ALO-KNT-302 |
| Study First Received: | December 21, 2006 |
| Results First Received: | September 11, 2009 |
| Last Updated: | October 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00415597 History of Changes |
| Health Authority: | United States: Food and Drug Administration |