Trial · NCT01129102
Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea
NCT01129102, Phase 3, Completed, Nobelpharma; results first posted 2014-06-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea. Trials, record NCT01129102. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01129102
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea
- NCT number
- NCT01129102
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 215 participants, actual
- Lead sponsor
- Nobelpharma
- Conditions
- Dysmenorrhea
- Interventions
- NPC-01, IKH-01, Placebo
- First posted
- 2010-05-24
- Last updated
- 2025-03-05
- Results first posted
- 2014-06-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) | 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 | Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-End of Treatment) | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) | 16weeks | Primary endpoints were analysed based on FAS population. Data unavailable for IKH-01 group because IKH-01 group only assigned for secondary dysmenorrhea. | units on a scale | MEAN |
| SECONDARY | Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-End of Treatment) | 16weeks | This analysis was carried out based on FAS population. IKH-01 was not allocated for primary dysmenorrhea in this study. Therefore, VAS for primary dysmenorrhea is not available in IKH-01 group. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) | NPC-01 | Pretreatment | 4.1 | Standard Deviation 1.00 | units on a scale |
| Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) | Placebo | Pretreatment | 4.2 | Standard Deviation 0.95 | units on a scale |
| Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) | NPC-01 | End of treatment | 1.8 | Standard Deviation 1.57 | units on a scale |
| Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) | Placebo | End of treatment | 2.9 | Standard Deviation 1.55 | units on a scale |
| Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-End of Treatment) | NPC-01 | Pretreatment | 51.8 | Standard Deviation 20.57 | units on a scale |
| Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-End of Treatment) | Placebo | Pretreatment | 48.6 | Standard Deviation 20.15 | units on a scale |
| Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-End of Treatment) | NPC-01 | End of treatment | 21.2 | Standard Deviation 20.18 | units on a scale |
| Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-End of Treatment) | Placebo | End of treatment | 35.6 | Standard Deviation 21.74 | units on a scale |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NPC-01 | 110 | |
| Overall Study | STARTED | IKH-01 | 50 | |
| Overall Study | STARTED | Placebo | 55 | |
| Overall Study | COMPLETED | NPC-01 | 102 | |
| Overall Study | COMPLETED | IKH-01 | 44 | |
| Overall Study | COMPLETED | Placebo | 48 | |
| Overall Study | NOT COMPLETED | NPC-01 | 8 | |
| Overall Study | NOT COMPLETED | IKH-01 | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 7 |
Source ClinicalTrials.gov
Adverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal discomfort | Gastrointestinal disorders | NPC-01 | 0 | 107 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | IKH-01 | 1 | 47 | 2 |
| other | Abdominal discomfort | Gastrointestinal disorders | Placebo | 3 | 54 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | NPC-01 | 6 | 107 | 9 |
| other | Abdominal pain | Gastrointestinal disorders | IKH-01 | 1 | 47 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 1 | 54 | 1 |
| other | Abdominal pain lower | Gastrointestinal disorders | NPC-01 | 12 | 107 | 19 |
| other | Abdominal pain lower | Gastrointestinal disorders | IKH-01 | 2 | 47 | 3 |
| other | Abdominal pain lower | Gastrointestinal disorders | Placebo | 1 | 54 | 3 |
| other | Abdominal pain upper | Gastrointestinal disorders | NPC-01 | 5 | 107 | 5 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NPC-01 | ||
| Total, all-cause mortality | IKH-01 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | NPC-01 | 103 | 107 |
| Total, other adverse events | IKH-01 | 45 | 47 |
| Total, other adverse events | Placebo | 44 | 54 |
| Total, serious adverse events | NPC-01 | 0 | 107 |
| Total, serious adverse events | IKH-01 | 1 | 47 |
| Total, serious adverse events | Placebo | 0 | 54 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01129102
GET https://conductscience.org/api/trials/v1/NCT01129102/events?page=2