Pilot Study of Tetomilast in Chronic Obstructive Pulmonary Disease (COPD) Associated With Emphysema (EMPHASIS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00874497 |
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Recruitment Status :
Terminated
(Sponsor Terminated)
First Posted : April 2, 2009
Results First Posted : April 17, 2017
Last Update Posted : April 17, 2017
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Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
| Condition |
Chronic Obstructive Pulmonary Disease |
| Interventions |
Drug: tetomilast Drug: placebo |
| Enrollment | 84 |
Participant Flow
| Recruitment Details | Of the 84 participants treated in the trial, 38 completed the trial and 10 participants were ongoing at the time the sponsor discontinued the trial. |
| Pre-assignment Details | Prior to randomization, each participant was in a 28- to 35-day screening period. Placebo was given for 14 days and a daily diary of symptom scores and actuations of albuterol/ipratropium bromide were collected. |
| Arm/Group Title | Tetomilast 50 mg | Placebo |
|---|---|---|
 Arm/Group Description |
Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks. | Participants were administered matching placebo for 104 weeks (2 years) |
| Period Title: Overall Study | ||
| Started | 51 [1] | 33 [1] |
| Completed | 23 | 15 |
| Not Completed | 28 | 18 |
| Reason Not Completed | ||
| Lost to Follow-up | 2 | 4 |
| Adverse Event | 9 | 4 |
| Sponsor Discontinued Trial | 7 | 3 |
| Met Withdrawal Criteria | 4 | 2 |
| Physician Decision | 1 | 1 |
| Withdrawal by Subject | 5 | 4 |
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[1]
This is the number of participants who were treated and were considered as safety population.
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Baseline Characteristics
| Arm/Group Title | Tetomilast 50 mg | Placebo | Total | |
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Arm/Group Description |
Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks. | Participants were administered matching placebo for 104 weeks (2 years) | Total of all reporting groups | |
| Overall Number of Baseline Participants | 51 | 33 | 84 | |
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Baseline Analysis Population Description |
The safety population included all randomized participants who had received study medication. Participants in this population were used for all demographic and safety summaries. Participants were analyzed based on the treatment which they had received.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 51 participants | 33 participants | 84 participants | |
| 58.0 (6.04) | 58.4 (7.71) | 58.2 (6.70) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 51 participants | 33 participants | 84 participants | |
| Female |
24 47.1%
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17 51.5%
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41 48.8%
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| Male |
27 52.9%
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16 48.5%
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43 51.2%
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Outcome Measures
Adverse Events
Limitations and Caveats
This trial was terminated early, not due to a safety concern, but due to a business decision to cease development of the tetolimast clinical program.
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 only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title: | Global Medical Affairs |
| Organization: | Otsuka Pharmaceutical Development and Commercialization, Inc. |
| Phone: | 800 562-3974 |
| Responsible Party: | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| ClinicalTrials.gov Identifier: | NCT00874497 |
| Other Study ID Numbers: |
197-08-250 |
| First Submitted: | March 31, 2009 |
| First Posted: | April 2, 2009 |
| Results First Submitted: | August 23, 2016 |
| Results First Posted: | April 17, 2017 |
| Last Update Posted: | April 17, 2017 |