Trial · NCT02024568
Exploratory Study on the Use of Pregabalin for the Treatment of Taxol Related Arthralgia-Myalgia
NCT02024568, Phase 2, Unknown, Assaf-Harofeh Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Exploratory Study on the Use of Pregabalin for the Treatment of Taxol Related Arthralgia-Myalgia. Trials, record NCT02024568. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02024568
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Exploratory Study on the Use of Pregabalin for the Treatment of Taxol Related Arthralgia-Myalgia
- NCT number
- NCT02024568
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 38 participants, estimated
- Lead sponsor
- Assaf-Harofeh Medical Center
- Conditions
- Taxane, Drug-related Side Effects and Adverse Reactions, Pain, Breast Cancer
- Interventions
- Pregabalin, Placebo
- First posted
- 2013-12-31
- Last updated
- 2013-12-31
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Integrated Numeric Pain Scores and Rescue Analgesic Medication Requirement as calculated by the method proposed by Silverman et al (Silverman, O'Connor et al. 1993). | 16 months from study initiation | Modern pain research acknowledges the subjective and complex nature of pain that complicates its assessment. Furthermore, ethical imperatives place constraints on the comparative control to serve the in evaluation of a novel analgesic intervention (Silverman, O'Connor et al. 1993). One of the solutions to this issue, using normalized ordinal evaluations of pain and analgesic drug consumption around a central value in a manner that also accounts for changes in analgesic drug requirements (Silverman, O'Connor et al. 1993) will serve for direct assessment of the study hypothesis. |
| Secondary | Numeric Pain Score (NPS) | 8 days after receiving cycle of paclitaxel | Numeric Pain score (NPS\*) evaluation of Myalgia / Arthralgia related pain. The scores to be considered will be the maximum values recorded over the course of the 7 days starting on the day the taxane is administered. \*Numerical Rating Scale: 0-1 No pain; 2-3 Mild pain; 4-5 Discomforting - moderate pain; 6-7 Distressing - severe pain; 8-9 Intense - very severe pain; 10 - Unbearable pain |
| Secondary | The additional number of hours spent in horizontal position (∆HHP**) | 8 days after receiving cycle of paclitaxel | The additional number of hours spent in horizontal position (∆HHP\*\*) as when lying down in bed, on couch, etc., during waking time will serve as an additional endpoint. It will be derived by subtracting the number of hours spent in horizontal position prior to taxane treatment from the number of hours in that position during the day with the highest pain score in the course of the week following treatment. Daytime hours will be calculated as the time between getting up in the morning and going to bed in the evening on the day preceding the infusion of the taxane. HHP - the number of Hours in Horizontal Position. ∆HHP - the additional number of hours in horizontal position; Post Treatment HHP - Baseline HHP = ∆HHP. |
| Secondary | FACT-taxane score | On day of recruitment to active phase + one week after 4th cycle of paclitaxel since recruitment to active phase. | The FACT-Taxane scale is a psychometric tool specifically developed to assess the impact of taxane based treatment on the quality of life (Cella, Peterman et al. 2003). Both the severity of pain and associated impact on daily activities, as well as established side effects of the study drug may affect the score on this scale. |
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.
Papers14
The papers the trial lists on ClinicalTrials.gov.
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/NCT02024568
GET https://conductscience.org/api/trials/v1/NCT02024568/registered