Trial · NCT00902746
Efficacy and Safety, Long-Term Study of NPC-01 to Treat Dysmenorrhea Associated With Endometriosis
NCT00902746, Phase 3, Completed, Nobelpharma; results first posted 2014-06-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety, Long-Term Study of NPC-01 to Treat Dysmenorrhea Associated With Endometriosis. Trials, record NCT00902746. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00902746
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety, Long-Term Study of NPC-01 to Treat Dysmenorrhea Associated With Endometriosis
- NCT number
- NCT00902746
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 149 participants, actual
- Lead sponsor
- Nobelpharma
- Conditions
- Dysmenorrhea
- Interventions
- NPC-01
- First posted
- 2009-05-15
- Last updated
- 2025-06-15
- Results first posted
- 2014-06-13
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) | 52 weeks | 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 Visual Analog Scale (VAS) of Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment) | 52 weeks | 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) | 52 weeks | This analysis was carried out for 112 patients whom end of study data was available on FAS. | units on a scale | MEAN |
| SECONDARY | Difference in the Visual Analog Scale (VAS) of Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment) | 52 weeks | This analysis was carried out for 112 patients whom end of study data was available on FAS. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group2
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 | 2.4 | Standard Deviation 1.80 | units on a scale | |
| Difference in the Visual Analog Scale (VAS) of Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment) | NPC-01 | 28.4 | Standard Deviation 25.13 | units on a scale |
Source ClinicalTrials.gov
Participant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NPC-01 | 149 | |
| Overall Study | Initiation of Study Drug Administration | NPC-01 | 148 | |
| Overall Study | Transfer to Step 2 | NPC-01 | 133 | |
| Overall Study | COMPLETED | NPC-01 | 113 | |
| Overall Study | NOT COMPLETED | NPC-01 | 36 |
Source ClinicalTrials.gov
Adverse events30
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 | 11 | 147 | 20 |
| other | Abdominal pain upper | Gastrointestinal disorders | NPC-01 | 17 | 147 | 29 |
| other | Constipation | Gastrointestinal disorders | NPC-01 | 10 | 147 | 10 |
| other | Dental caries | Gastrointestinal disorders | NPC-01 | 12 | 147 | 13 |
| other | Diarrhoea | Gastrointestinal disorders | NPC-01 | 14 | 147 | 34 |
| other | Gastritis | Gastrointestinal disorders | NPC-01 | 9 | 147 | 9 |
| other | Nausea | Gastrointestinal disorders | NPC-01 | 25 | 147 | 42 |
| other | Malaise | General disorders | NPC-01 | 13 | 147 | 17 |
| other | Cystitis | Infections and infestations | NPC-01 | 9 | 147 | 9 |
| other | Gastroenteritis | Infections and infestations | NPC-01 | 13 | 147 | 14 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NPC-01 | ||
| Total, other adverse events | NPC-01 | 147 | 147 |
| Total, serious adverse events | NPC-01 | 5 | 147 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00902746
GET https://conductscience.org/api/trials/v1/NCT00902746/events?page=2