Trial · NCT02402530
Efficacy and Safety of Intravenous Neridronic Acid in CRPS-I
NCT02402530, Phase 2, Phase 3, Completed, Grünenthal GmbH
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Intravenous Neridronic Acid in CRPS-I. Trials, record NCT02402530. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02402530
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Intravenous Neridronic Acid in CRPS-I
- NCT number
- NCT02402530
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 459 participants, actual
- Lead sponsor
- Grünenthal GmbH
- Conditions
- Complex Regional Pain Syndrome, Type I
- Interventions
- Placebo, Neridronic acid 62.5 mg
- First posted
- 2015-03-30
- Last updated
- 2018-05-09
- Other registries' IDs
- eudract:2014-001915-37
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the Pain Intensity Score to Week 12. | Baseline; Week 12 | The Pain Intensity Score is the mean value of current pain intensity ratings, obtained twice-daily for 1 week, using an 11-point numerical rating scale where 0 = "no pain" and 10 = "pain as bad as you can imagine". All pain intensity ratings for the primary endpoint will be in reference to the CRPS-affected limb. |
| Secondary | Response to treatment: Proportion of Participants With at Least 30 Percent Reduction in the Pain Intensity Score | Baseline; Week 12 | Participants with at least a 30 percent decrease in the Pain Intensity Score will be considered to have responded to treatment. The Pain Intensity Score is determined as for the primary endpoint. |
| Secondary | Response to treatment: Proportion of Participants With at Least 50 Percent Reduction in the Pain Intensity Score | Baseline; Week 12 | Participants with at least a 50 percent decrease in the Pain Intensity Score will be considered to have responded to treatment. The Pain Intensity Score is determined as for the primary endpoint. |
| Secondary | Change in the Brief Pain Inventory (BPI) Interference Score | Baseline; Week 12 | The BPI Interference Score is the mean value of 7 self-reported items in question 9 of the BPI Short Form Questionnaire. Participants will rate their interference of pain with general activity, walking, work, sleep and other activities in the past 24 hours, with possible ratings from 0 (does not interfere) to 10 (completely interferes). The BPI interference Score ranges from 0 to 10, with higher values indicating greater pain interference of daily activities. |
| Secondary | Patient Global Impression of Change (PGIC) | Baseline; Week 12 | The PGIC is a self-reported measure of perceived change in overall condition since the start of the study. Participants will select one of seven responses ranging from very much improved to very much worse. A response of very much improved or much improved is generally regarded as a clinically important outcome. |
| Secondary | Change in the EuroQol-5 Dimension 5 Level (EQ-5D-5L) Index Score | Baseline; Week 12 | The EQ-5D-5L Index Score describes the participant's overall health status and is derived from self-reported scores in 5 health dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Participants will rate each dimension at one of 5 levels, with level 1 indicating the best health state (no problems) and level 5 indicating worst health state (e.g., unable to walk about). The EQ-5D-5L Index Score ranges from 0 to 1, with 0 representing death and 1.0 representing perfect health. |
| Secondary | Change in the EuroQol Visual Analog Scale (EQ VAS) | Baseline; Week 12 | The EQ VAS is a self-reported measure of the participant's overall health "today". Participants will place a mark on a 20 cm vertical scale numbered from 0 to 100, with 0 labeled as "the worst health you can imagine" and 100 labeled as "the best health you can imagine". The EQ VAS ranges from 0 to 100, with higher scores representing better overall health. |
| Other | Change in the Worst Pain Intensity | Baseline; Week 12 | This will be determined as for the primary endpoint, using worst pain intensity ratings. Participants will rate their worst pain intensity during the previous 12 hours twice each day using an 11-point numerical rating scale where 0 = "no pain" and 10 = "pain as bad as you can imagine". Worst pain intensity ratings are in reference to the CRPS-affected limb. |
| Other | Change in the Average Pain Intensity | Baseline; Week 12 | This will be determined as for the primary endpoint, using average pain intensity ratings. Participants will rate their average pain intensity during the previous 12 hours twice each day using an 11-point numerical rating scale where 0 = "no pain" and 10 = "pain as bad as you can imagine". Average pain intensity ratings are in reference to the CRPS-affected limb. |
| Other | Change from Baseline in the Pain Intensity Scores at Each Week | Baseline to Week 12 | Pain Intensity Scores will be determined as for the primary endpoint using current pain intensity ratings obtained twice-daily. Mean values will be assessed during each of the first 12 weeks of the study. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT02402530
GET https://conductscience.org/api/trials/v1/NCT02402530/registered?page=2