Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nobelpharma
ClinicalTrials.gov Identifier:
NCT01129102
First received: May 21, 2010
Last updated: May 15, 2014
Last verified: May 2014
Results First Received: April 10, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Dysmenorrhea
Interventions: Drug: NPC-01
Drug: IKH-01
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
NPC-01

Norethisterone 1mg, Ethinyl estradiol 0.02mg

NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg

IKH-01

Norethisterone 1mg, Ethinyl estradiol 0.035mg

IKH-01: Norethisterone 1mg, Ethinyl estradiol 0.035mg

Placebo

Placebo for NPC-01

Placebo: Placebo for NPC-01


Participant Flow:   Overall Study
    NPC-01     IKH-01     Placebo  
STARTED     110     50     55  
COMPLETED     102     44     48  
NOT COMPLETED     8     6     7  
No study drug treatment                 2                 3                 1  
Withdrawal by Subject                 2                 0                 3  
Protocol Violation                 0                 1                 1  
Pregnancy                 0                 0                 1  
Adverse Event                 2                 2                 1  
Lost to Follow-up                 2                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline analysis population was carried out based on FAS data set. 110, 50 and 55 pts were assigned to NPC-01, IKH-01 and placebo, respectively, and administered study drug 108, 47 and 54 pts. Safety and FAS analysis was carried out on 107, 47 and 54 pts/105, 47 and 54 pts due to 1 and 2 pts of NPC-01 have no available data respectively.

Reporting Groups
  Description
NPC-01 Norethisterone 1mg, Ethinyl estradiol 0.02mg
IKH-01 Norethisterone 1mg, Ethinyl estradiol 0.035mg
Placebo Placebo for NPC-01
Total Total of all reporting groups

Baseline Measures
    NPC-01     IKH-01     Placebo     Total  
Number of Participants  
[units: participants]
  105     47     54     206  
Age  
[units: years]
Mean ± Standard Deviation
  32.4  ± 7.29     34.0  ± 6.93     30.4  ± 7.41     32.3  ± 7.21  
Age, Customized  
[units: participants]
       
Under 30 years of age     39     13     29     81  
30 year of age and older     66     34     25     125  
Gender, Customized  
[units: participants]
       
Female     105     47     54     206  
Diagnostic categories  
[units: participants]
       
Primary dysmenorrhea     55     0     28     83  
Secondary dysmenorrhea     50     47     26     123  
Total dysmenorrhea score [1]
[units: units on a scale]
Mean ± Standard Deviation
       
Total dysmenorrhea     4.1  ± 1.00     NA  ± NA [3]   4.2  ± 0.95     NA  ± NA [2]
Primary dysmenorrhea     3.9  ± 0.92     NA  ± NA [4]   4.3  ± 0.90     NA  ± NA [2]
Secondary dysmenorrhea     4.3  ± 1.05     4.0  ± 0.87     4.1  ± 0.99     4.1  ± 0.96  
Visual analogue scale (VAS) for primary dysmenorrhea [5]
[units: units on a scale]
Mean ± Standard Deviation
  51.8  ± 20.57     NA  ± NA [6]   48.6  ± 20.15     NA  ± NA [2]
[1]

The detail of dysmenorrhea score that was used in this study is the following. These subscales summed for a total dysmenorrhea score (minimum 0 to maximum 6). Pain score None 0 : None Mild 1 : There are some troubles for work Moderate 2 : Needing to rest in bed and/or affecting work Severe 3 : Morre than 1 day in bed and not possible to work

Drug score (during a menstrual period) None 0 : None Mild 1 : taking analgesics for 1 days Moderate 2 : taking analgesics for 2 days Severe 3 : taking analgesics more than 3 days

[2] Data unavailable for IKH-01 group
[3] IKH-01 was not allocated for primary dysmenorrhea in this study. Therefore, total dysmenorrhea score is not available for IKH-01 group.
[4] IKH-01 was not allocated for primary dysmenorrhea in this study.
[5] VAS stands for Visual Analogue Scale of pain. The scale was rated as a graphic rating scale. as a 100mm baseline from 0:No pain to 100:Worst possible pain.
[6] IKH-01 was not allocated for primary dysmenorrhea in this study. Therefore, VAS for primary dysmenorrhea is not available for IKH-01 group.



  Outcome Measures
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1.  Primary:   Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)   [ Time Frame: 16weeks ]

2.  Secondary:   Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-End of Treatment)   [ Time Frame: 16weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
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:
unchecked 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. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Department director of clinical development department 1
Organization: Nobelpharma
phone: +81-5651-1177
e-mail: murakami@nobelpharma.co.jp


No publications provided


Responsible Party: Nobelpharma
ClinicalTrials.gov Identifier: NCT01129102     History of Changes
Other Study ID Numbers: NPC-01-2
Study First Received: May 21, 2010
Results First Received: April 10, 2014
Last Updated: May 15, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency