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 |
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 Results
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Study Type | Interventional |
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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. |
Baseline Characteristics
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 History of Changes |
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 |