Trial · NCT04321408
OP2C : Prialt® Observatory in Clinical Practice
NCT04321408, Recruiting, Institut Cancerologie de l'Ouest
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. OP2C : Prialt® Observatory in Clinical Practice. Trials, record NCT04321408. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04321408
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- OP2C : Prialt® Observatory in Clinical Practice
- NCT number
- NCT04321408
- Status
- Recruiting
- Enrollment
- 300 participants, estimated
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Conditions
- Refractory Pain
- Interventions
- Ziconotide Injection
- First posted
- 2020-03-25
- Last updated
- 2025-08-17
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Describe the practical methods of using intrathecal treatments containing ziconotide: indication, initial intrathecal analgesic treatment and evolution of intrathecal analgesic treatment, efficacy and safety in the real clinical practice and monitoring. | 7 years | Indication, initial intrathecal analgesic treatment and evolution of intrathecal analgesic treatment and monitoring. |
| Secondary | Describe the tolerability to intrathecal ziconotide treatment | 7 years | Tolerability will be assessed by asking questions, clinical examination and paraclinical examinations at each visit |
| Secondary | Describe the efficacy on pain of intrathecal ziconotide treatment | 7 years | The efficacy of the analgesic treatment is measured based on the numeric pain rating scale (0 to 10) at start of Ziconotide, 1, 3, 6, 12 months, and every 12 months thereafter |
| Secondary | Estimate the duration of treatment according to the indication | 7 years | Time between the first and last date of administration of intrathecal ziconotide during study. |
| Secondary | Subgroup comparative analysis | 7 years | Subgroup comparative analysis will be conducted according to initial characteristics, doses course progress of ziconotide and according to efficacy and tolerability. |
| Secondary | Responders profile detection | 7 years | Responders profile according to efficacy on pain of intrathecal ziconotide treatment |
| Secondary | Describe quality of life under ziconotide treatment | 7 years | f) The Quality of life will be assessed by EQ5D-5L questionnaires under intrathecal ziconotide treatment, at 1, 3, 6, 12 months, and every 12 months thereafter until the registry remains open |
Source ClinicalTrials.gov
Outcomes0
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42189020 | DERIVED |
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/NCT04321408
GET https://conductscience.org/api/trials/v1/NCT04321408/registered