Trial · NCT03560986
Efficacy and Safety of Intravenous Neridronic Acid in Complex Regional Pain Syndrome (CRPS)
NCT03560986, Phase 3, Terminated, Grünenthal GmbH; results first posted 2020-08-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Intravenous Neridronic Acid in Complex Regional Pain Syndrome (CRPS). Trials, record NCT03560986. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03560986
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Intravenous Neridronic Acid in Complex Regional Pain Syndrome (CRPS)
- NCT number
- NCT03560986
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 267 participants, actual
- Lead sponsor
- Grünenthal GmbH
- Conditions
- Complex Regional Pain Syndrome (CRPS)
- Interventions
- Neridronic acid 100 mg, Placebo
- First posted
- 2018-06-19
- Last updated
- 2020-08-05
- Other registries' IDs
- eudract:2017-004244-37
- Results first posted
- 2020-08-05
- Limitations and caveats
A pre-specified interim analysis was conducted on pooled primary endpoint data of studies KF7013-04 and KF7013-02 (NCT03530345). The interim analysis indicated futility (neridronate unlikely to be superior to placebo) and both studies were stopped.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 12 in the Average Pain Intensity Score (Weekly Average of Pain Values Recorded Daily in the Electronic Diary) | From the Baseline Phase (Day -7 to Day -1) to Week 12 | In the Baseline Phase and in Treatment Period A/Follow-up Period 1, participants were asked to assessed their average CRPS-related pain on an 11-point numerical rating scale (NRS) - from 0 = "no pain" to 10 = "pain as bad as you can imagine" and report it once daily (in the evening, 24-hour recall) in an electronic diary. Changes from baseline (average for the Baseline Phase) to the weekly average for Week 12 were calculated. |
| Secondary | Change From Baseline to Week 26 in the Average Pain Intensity Recorded on the Tablet Computer | From baseline (Visit 2 [Day 1]) to Visit 11 (Week 26) | 11-point NRS - from 0 = "no pain" to 10 = "pain as bad as you can imagine" - reported at the visits on a tablet computer (24-hour recall). Changes from baseline to Week 26 were planned to be analyzed. |
| Secondary | Pain Response to Treatment, Defined as at Least 30% Decrease From Baseline in the Average Pain Intensity at Week 12, Recorded on the Tablet Computer | From baseline (Visit 2 [Day 1]) to Visit 8 (Week 12) | 11-point NRS - from 0 = "no pain" to 10 = "pain as bad as you can imagine" - reported at the visits on a tablet computer (24-hour recall). The number of participants with response at Week 12 was planned to be determined. |
| Secondary | Pain Response to Treatment, Defined as at Least 30% Decrease From Baseline in the Average Pain Intensity at Week 26, Recorded on the Tablet Computer | From baseline (Visit 2 [Day 1]) to Visit 11 (Week 26) | 11-point NRS - from 0 = "no pain" to 10 = "pain as bad as you can imagine" - reported at the visits on a tablet computer (24-hour recall). The number of participants with response at Week 26 was planned to be determined. |
| Secondary | Change From Baseline to Week 12 in the Pain Intensity Level of Dynamic Mechanical Allodynia (DMA) | From baseline (Visit 2 [Day 1]) to Visit 8 (Week 12) | Dynamic mechanical allodynia: a tactile stimulus is applied in a single sweeping motion (1 cm to 2 cm length) on the skin on the affected limb. The participants are asked to judge the stimulus intensity by means of an NRS (0 to 10). "0" in this case means "no pain". Each "pricking", "stinging" or "burning" sensation is defined as a painful sensation, which should always be evaluated by giving a value greater than "0". "10" corresponds to the individual maximum pain imaginable. Change from baseline was planned to analyzed. |
| Secondary | Change From Baseline to Week 12 in the Pressure Pain Threshold (PPT) Ratio for the Thenar Muscle/Abductor Hallucis Muscle | From baseline (Visit 2 [Day 1]) to Visit 8 (Week 12) | Pressure pain threshold: using a pressure algometer (contact area 1 cm2), the threshold for pressure-induced pain is measured on the thenar muscle/abductor hallucis muscle in 3 series of slowly increasing stimulus intensities (at a rate of about 50 kPa/s). The threshold is then determined as the arithmetic mean of the 3 series (in kPa). The ratio of the thresholds of the affected limb versus the unaffected limb was planned to be calculated. |
| Secondary | Change From Baseline to Week 12 in the Ratio of the Figure of Eight Measurements of the Affected Limb Versus the Unaffected Limb | From baseline (Visit 2 [Day 1]) to Visit 8 (Week 12) | In participants with the CRPS sign of edema on the CRPS severity score at baseline, circumference of the hand or foot will be measured by the investigator with measurement tape using the figure-of-eight method at both the affected limb and the contralateral unaffected limb. Each measurement will be performed 3 times. The average of the 3 measurements will be used for further analysis. The ratio of the averages of the affected limb versus the unaffected limb was planned to be calculated and used for the determination of the change from baseline. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 12 in the Average Pain Intensity Score (Weekly Average of Pain Values Recorded Daily in the Electronic Diary) | From the Baseline Phase (Day -7 to Day -1) to Week 12 | Full Analysis Set; all participants treated in Treatment Period A with all data available at the time of last participant out following premature study termination. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 26 in the Average Pain Intensity Recorded on the Tablet Computer | From baseline (Visit 2 [Day 1]) to Visit 11 (Week 26) | Data were not collected or analyzed because a confirmatory testing strategy was not performed as pre-specified in the protocol that secondary endpoints would only be tested if neridronic acid was superior to placebo on the primary outcome measure. A confirmatory or descriptive analysis was not performed due to early study termination. | ||
| SECONDARY | Pain Response to Treatment, Defined as at Least 30% Decrease From Baseline in the Average Pain Intensity at Week 12, Recorded on the Tablet Computer | From baseline (Visit 2 [Day 1]) to Visit 8 (Week 12) | Data were not collected or analyzed because a confirmatory testing strategy was not performed as pre-specified in the protocol that secondary endpoints would only be tested if neridronic acid was superior to placebo on the primary outcome measure. A confirmatory or descriptive analysis was not performed due to early study termination. | ||
| SECONDARY | Pain Response to Treatment, Defined as at Least 30% Decrease From Baseline in the Average Pain Intensity at Week 26, Recorded on the Tablet Computer | From baseline (Visit 2 [Day 1]) to Visit 11 (Week 26) | Data were not collected or analyzed because a confirmatory testing strategy was not performed as pre-specified in the protocol that secondary endpoints would only be tested if neridronic acid was superior to placebo on the primary outcome measure. A confirmatory or descriptive analysis was not performed due to early study termination. | ||
| SECONDARY | Change From Baseline to Week 12 in the Pain Intensity Level of Dynamic Mechanical Allodynia (DMA) | From baseline (Visit 2 [Day 1]) to Visit 8 (Week 12) | Data were not collected or analyzed because a confirmatory testing strategy was not performed as pre-specified in the protocol that secondary endpoints would only be tested if neridronic acid was superior to placebo on the primary outcome measure. A confirmatory or descriptive analysis was not performed due to early study termination. | ||
| SECONDARY | Change From Baseline to Week 12 in the Pressure Pain Threshold (PPT) Ratio for the Thenar Muscle/Abductor Hallucis Muscle | From baseline (Visit 2 [Day 1]) to Visit 8 (Week 12) | Data were not collected or analyzed because a confirmatory testing strategy was not performed as pre-specified in the protocol that secondary endpoints would only be tested if neridronic acid was superior to placebo on the primary outcome measure. A confirmatory or descriptive analysis was not performed due to early study termination. | ||
| SECONDARY | Change From Baseline to Week 12 in the Ratio of the Figure of Eight Measurements of the Affected Limb Versus the Unaffected Limb | From baseline (Visit 2 [Day 1]) to Visit 8 (Week 12) | Data were not collected or analyzed because a confirmatory testing strategy was not performed as pre-specified in the protocol that secondary endpoints would only be tested if neridronic acid was superior to placebo on the primary outcome measure. A confirmatory or descriptive analysis was not performed due to early study termination. |
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 |
|---|---|---|---|---|---|
| Change From Baseline to Week 12 in the Average Pain Intensity Score (Weekly Average of Pain Values Recorded Daily in the Electronic Diary) | Neridronic Acid - Treatment Period A | -1.28 | Standard Error 0.270 | units on a scale | |
| Change From Baseline to Week 12 in the Average Pain Intensity Score (Weekly Average of Pain Values Recorded Daily in the Electronic Diary) | Placebo - Treatment Period A | -1.71 | Standard Error 0.268 | units on a scale |
Source ClinicalTrials.gov
Participant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period A/Follow-up Period 1 | STARTED | Neridronic Acid - Treatment Period A | 48 | |
| Treatment Period A/Follow-up Period 1 | STARTED | Placebo - Treatment Period A | 51 | |
| Treatment Period A/Follow-up Period 1 | Treatment Period A Completers | Neridronic Acid - Treatment Period A | 45 | |
| Treatment Period A/Follow-up Period 1 | Treatment Period A Completers | Placebo - Treatment Period A | 45 | |
| Treatment Period A/Follow-up Period 1 | COMPLETED | Neridronic Acid - Treatment Period A | 12 | |
| Treatment Period A/Follow-up Period 1 | COMPLETED | Placebo - Treatment Period A | 13 | |
| Treatment Period A/Follow-up Period 1 | NOT COMPLETED | Neridronic Acid - Treatment Period A | 36 | |
| Treatment Period A/Follow-up Period 1 | NOT COMPLETED | Placebo - Treatment Period A | 38 | |
| Treatment Period B/Follow-up Period 2 | STARTED | Neridronic Acid - Treatment Period A | 9 | |
| Treatment Period B/Follow-up Period 2 | STARTED | Placebo - Treatment Period A | 8 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events342
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 | Diarrhoea | Gastrointestinal disorders | Baseline to Week 26: Placebo TPA | 2 | 51 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Baseline to Week 26: Neridronic Acid TPA | 2 | 48 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Week 26 to Week 52: Placebo TPA | 0 | 43 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Week 26 to Week 52: Placebo TPA, Neridronic Acid TPB | 1 | 8 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Week 26 to Week 52: Neridronic Acid TPA | 0 | 39 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Week 26 to Week 52: Neridronic Acid TPA, Neridronic Acid TPB | 0 | 9 | 0 |
| other | Nausea | Gastrointestinal disorders | Baseline to Week 26: Placebo TPA | 8 | 51 | 12 |
| other | Nausea | Gastrointestinal disorders | Baseline to Week 26: Neridronic Acid TPA | 2 | 48 | 2 |
| other | Nausea | Gastrointestinal disorders | Week 26 to Week 52: Placebo TPA | 0 | 43 | 0 |
| other | Nausea | Gastrointestinal disorders | Week 26 to Week 52: Placebo TPA, Neridronic Acid TPB | 2 | 8 | 5 |
1 to 10 of 342Source ClinicalTrials.gov
See all 342 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Baseline to Week 26: Placebo TPA | 0 | 51 |
| Total, all-cause mortality | Baseline to Week 26: Neridronic Acid TPA | 0 | 48 |
| Total, all-cause mortality | Week 26 to Week 52: Placebo TPA | 0 | 43 |
| Total, all-cause mortality | Week 26 to Week 52: Placebo TPA, Neridronic Acid TPB | 0 | 8 |
| Total, all-cause mortality | Week 26 to Week 52: Neridronic Acid TPA | 0 | 39 |
| Total, all-cause mortality | Week 26 to Week 52: Neridronic Acid TPA, Neridronic Acid TPB | 0 | 9 |
| Total, other adverse events | Baseline to Week 26: Placebo TPA | 40 | 51 |
| Total, other adverse events | Baseline to Week 26: Neridronic Acid TPA | 40 | 48 |
| Total, other adverse events | Week 26 to Week 52: Placebo TPA | 1 | 43 |
| Total, other adverse events | Week 26 to Week 52: Placebo TPA, Neridronic Acid TPB | 6 | 8 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
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.
GET https://conductscience.org/api/trials/v1/NCT03560986
GET https://conductscience.org/api/trials/v1/NCT03560986/events?page=2