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Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01129102
First Posted: May 24, 2010
Last Update Posted: June 17, 2014
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.
Information provided by (Responsible Party):
Nobelpharma
  Purpose
The purpose of this study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea.

Condition Intervention Phase
Dysmenorrhea Drug: NPC-01 Drug: IKH-01 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3, Placebo Controlled, Randomized, Double-blinded, Nonsteroidal Antiinflammatory Drug add-on, Clinical Trial of NPC-01 for Treatment of Dysmenorrhea

Resource links provided by NLM:


Further study details as provided by Nobelpharma:

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

    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



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


Enrollment: 215
Study Start Date: May 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NPC-01
Norethisterone 1mg, Ethinyl estradiol 0.02mg
Drug: NPC-01
Norethisterone 1mg, Ethinyl estradiol 0.02mg
Active Comparator: IKH-01
Norethisterone 1mg, Ethinyl estradiol 0.035mg
Drug: IKH-01
Norethisterone 1mg, Ethinyl estradiol 0.035mg
Placebo Comparator: Placebo
Placebo for NPC-01
Drug: Placebo
Placebo for NPC-01

Detailed Description:

The main objective of this study is to confirm the effectiveness and safety profile of NPC-01 in comparison with placebo in the treatment of dysmenorrhea (primary and secondary dysmenorrhea).

Additionally we also investigate the differences of effectiveness of NPC-01 in comparison with IKH-01 in the treatment of secondary dysmenorrhea as a reference, because IKH-01 is already marketed at them.

To achieve these, closed testing procedure is used in this study. After confirming statistical differences between NPC-01 and Placebo in the total dysmenorrhea, stratified analysis is carried out for primary dysmenorrhea (NPC-01, Placebo), and secondary dysmenorrhea (NPC-01, IKH-01 and Placebo).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • dysmenorrhea

Exclusion Criteria:

  • severe hepatopathy
  • pregnant woman
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01129102


Sponsors and Collaborators
Nobelpharma
Investigators
Study Director: Naoki Terakawa, M.D.,Ph.D. Nissay Hospital,Osaka,Japan
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nobelpharma
ClinicalTrials.gov Identifier: NCT01129102     History of Changes
Other Study ID Numbers: NPC-01-2
First Submitted: May 21, 2010
First Posted: May 24, 2010
Results First Submitted: April 10, 2014
Results First Posted: June 17, 2014
Last Update Posted: June 17, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Norethindrone
Norethindrone acetate
Anti-Inflammatory Agents, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents