Trial · NCT02972359
Safety of Intravenous Neridronic Acid in CRPS
NCT02972359, Phase 3, Completed, Grünenthal GmbH; results first posted 2019-11-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety of Intravenous Neridronic Acid in CRPS. Trials, record NCT02972359. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02972359
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety of Intravenous Neridronic Acid in CRPS
- NCT number
- NCT02972359
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 580 participants, actual
- Lead sponsor
- Grünenthal GmbH
- Conditions
- Complex Regional Pain Syndrome
- Interventions
- Neridronic acid
- First posted
- 2016-11-23
- Last updated
- 2019-11-21
- Other registries' IDs
- eudract:2016-001164-11
- Results first posted
- 2019-11-04
- Limitations and caveats
Due to the open-label, uncontrolled nature of the trial and the concomitant use of pain medication, the effect of neridronic acid on pain intensity and the side effect profile of neridronic acid have to be interpreted with care.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Occurrence of Any Treatment Emergent Adverse Event (TEAE) | Day 1 to Week 52 | The primary endpoint of this trial was a binary endpoint assessing whether or not a participant experienced any TEAE. |
| Secondary | Number of Participants With Occurrence of Permanent Discontinuation From Treatment Due to an Adverse Event | Day 1 to Day 10 | The investigator could choose to permanently discontinue a participant from treatment if continued exposure of the participant to neridronic acid could have posed an undue risk to the participant. |
| Secondary | Change From Baseline in the Current Pain Intensity Score | Baseline to Week 12 and Week 26 | The current Complex Regional Pain Syndrome (CRPS)-related pain intensity score was captured at each visit using an 11-point numerical rating scale where 0 = "no pain" and 10 = "pain as bad as you can imagine", a higher score indicates more pain. |
| Secondary | Number of Participants With Response to Treatment, Defined as at Least 30% Decrease From Baseline in the Current Pain Intensity Score | Baseline, at Week 12 and Week 26 | Participants with at least a 30 percent decrease in the current pain intensity score were considered to have responded to treatment. |
| Secondary | Number of Participants With Response to Treatment, Defined as at Least 50% Decrease From Baseline in the Current Pain Intensity Score | Baseline, at Week 12 and Week 26 | Participants with at least a 50 percent decrease in the current pain intensity score were considered to have responded to treatment. |
| Secondary | Patient Global Impression of Change (PGIC) at Week 12 | at Week 12 | The Patient Global Impression of Change (PGIC) is a self-reported measure of perceived change in overall condition since the start of the study. Participants selected 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 improvement. |
| Secondary | Patient Global Impression of Change (PGIC) at Week 26 | at Week 26 | The Patient Global Impression of Change (PGIC) is a self-reported measure of perceived change in overall condition since the start of the study. Participants selected 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 improvement. |
| Secondary | Change in the Pain Interference Score of the Brief Pain Inventory (BPI) | Baseline to Week 12 and Week 26 | The Brief Pain Inventory (BPI) Interference Score is the mean value of 7 self-reported items in question 9 of the BPI Short Form Questionnaire. Participants rated 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Occurrence of Any Treatment Emergent Adverse Event (TEAE) | Day 1 to Week 52 | Safety Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Occurrence of Permanent Discontinuation From Treatment Due to an Adverse Event | Day 1 to Day 10 | Safety Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in the Current Pain Intensity Score | Baseline to Week 12 and Week 26 | Full Analysis Set | units on a scale | MEAN |
| SECONDARY | Number of Participants With Response to Treatment, Defined as at Least 30% Decrease From Baseline in the Current Pain Intensity Score | Baseline, at Week 12 and Week 26 | Full Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Response to Treatment, Defined as at Least 50% Decrease From Baseline in the Current Pain Intensity Score | Baseline, at Week 12 and Week 26 | Full Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Patient Global Impression of Change (PGIC) at Week 12 | at Week 12 | Full Analysis Set; 286 out of 316 participants attended the visit at Week 12 and were asked to complete the PGIC questionnaire. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Patient Global Impression of Change (PGIC) at Week 26 | at Week 26 | Full Analysis Set; 273 out of 316 participants attended the visit at Week 26 and were asked to complete the PGIC questionnaire. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in the Pain Interference Score of the Brief Pain Inventory (BPI) | Baseline to Week 12 and Week 26 | Full Analysis Set | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Occurrence of Any Treatment Emergent Adverse Event (TEAE) | Neridronic Acid | Participants with TEAE | 277 | Participants | |
| Number of Participants With Occurrence of Any Treatment Emergent Adverse Event (TEAE) | Neridronic Acid | Participants with serious TEAE | 27 | Participants | |
| Number of Participants With Occurrence of Any Treatment Emergent Adverse Event (TEAE) | Neridronic Acid | Participants with non-serious TEAE | 275 | Participants | |
| Number of Participants With Occurrence of Any Treatment Emergent Adverse Event (TEAE) | Neridronic Acid | Participants with unexpected TEAE | 267 | Participants | |
| Number of Participants With Occurrence of Any Treatment Emergent Adverse Event (TEAE) | Neridronic Acid | Participants with related TEAE | 190 | Participants | |
| Number of Participants With Occurrence of Any Treatment Emergent Adverse Event (TEAE) | Neridronic Acid | Participants with related serious TEAE | 3 | Participants | |
| Number of Participants With Occurrence of Any Treatment Emergent Adverse Event (TEAE) | Neridronic Acid | Participants with TEAE leading to IMP discont. | 12 | Participants | |
| Number of Participants With Occurrence of Any Treatment Emergent Adverse Event (TEAE) | Neridronic Acid | Participants with TEAE leading to trial discont. | 6 | Participants | |
| Number of Participants With Occurrence of Permanent Discontinuation From Treatment Due to an Adverse Event | Neridronic Acid | 12 | Participants | ||
| Change From Baseline in the Current Pain Intensity Score | Neridronic Acid | Baseline to Week 12 | -1.54 | Standard Deviation 2.27 | units on a scale |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Neridronic Acid | 318 | |
| Overall Study | COMPLETED | Neridronic Acid | 247 | |
| Overall Study | NOT COMPLETED | Neridronic Acid | 71 |
Source ClinicalTrials.gov
Adverse events34
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 | Headache | Nervous system disorders | Neridronic Acid | 65 | 316 | 96 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Neridronic Acid | 52 | 316 | 70 |
| other | Nausea | Gastrointestinal disorders | Neridronic Acid | 34 | 316 | 46 |
| other | Fatigue | General disorders | Neridronic Acid | 32 | 316 | 39 |
| other | Condition aggravated | General disorders | Neridronic Acid | 30 | 316 | 44 |
| other | Pain | General disorders | Neridronic Acid | 28 | 316 | 37 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Neridronic Acid | 27 | 316 | 31 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Neridronic Acid | 25 | 316 | 30 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Neridronic Acid | 25 | 316 | 30 |
| other | Pyrexia | General disorders | Neridronic Acid | 18 | 316 | 19 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Neridronic Acid | 1 | 316 |
| Total, other adverse events | Neridronic Acid | 275 | 316 |
| Total, serious adverse events | Neridronic Acid | 27 | 316 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19414839 | BACKGROUND |
Source PubMed
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.
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GET https://conductscience.org/api/trials/v1/NCT02972359/results?page=2