Efficacy and Safety, Long-Term Study of NPC-01 to Treat Dysmenorrhea Associated With Endometriosis
This study has been completed.
Sponsor:
Nobelpharma
Information provided by (Responsible Party):
Nobelpharma
ClinicalTrials.gov Identifier:
NCT00902746
First received: May 7, 2009
Last updated: April 26, 2012
Last verified: April 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 7, 2009 | ||||
| Last Updated Date | April 26, 2012 | ||||
| Start Date ICMJE | May 2009 | ||||
| Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
patient response to treatment for dysmenorrhea, as evaluated by verbal rating scale (VRS) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00902746 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
change in the visual analog scale (VAS) of dysmenorrhea [ Time Frame: 52 weeks ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy and Safety, Long-Term Study of NPC-01 to Treat Dysmenorrhea Associated With Endometriosis | ||||
| Official Title ICMJE | Phase3, Open-Label, Long-Term, NSAID-Add-on, Clinical Trial of NPC-01 for Treatment of Dysmenorrhea Associated With Endometriosis. | ||||
| Brief Summary | The purpose of this long-term study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea associated with endometriosis. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Dysmenorrhea | ||||
| Intervention ICMJE | Drug: NPC-01
Norethindrone, Ethinyl Estradiol |
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| Study Arm (s) | Experimental: NPC-01
Intervention: Drug: NPC-01 |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 148 | ||||
| Completion Date | February 2012 | ||||
| Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00902746 | ||||
| Other Study ID Numbers ICMJE | NPC-01-1 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Nobelpharma | ||||
| Study Sponsor ICMJE | Nobelpharma | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Nobelpharma | ||||
| Verification Date | April 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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