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NCT01279850: RAINBOW-L
SPECIAL INVESTIGATION OF LONG TERM USE OF LYRICA(REGULATORY POST MARKETING COMMITMENT PLAN)
trial testing Pregabalin (Lyrica) capsule in Neuropathic Pain in 891 participants. Completed in 1 July 2017.
1 July 2017
Quick facts
| Lead sponsor | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 891 |
| Start date | 1 August 2011 |
| Primary completion | 1 July 2017 |
| Estimated completion | 1 July 2017 |
Drugs / interventions tested
- Pregabalin (Lyrica) capsule
Conditions studied
- Neuropathic Pain — all drugs for Neuropathic Pain →
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. — full company profile →
Who can join
0 Days and older, any sex, with Neuropathic Pain. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Percentage of Participants With Adverse Drug Reaction
Time frame: From Week 1 to Week 104 at maximum
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician.
Sponsor's own description
The objective of this investigation is to evaluate the safety and efficacy of long term use with Lyrica in medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in subjects treated with Lyrica will be monitored during the survey period, and whether an additional treatment outcome investigation and/or a post-marketing clinical study is required in the future will be determined.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01279850
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Pregabalin (Lyrica) capsule
Trials testing the same drug.
- NCT01256593 — Safety And Efficacy Of Lyrica (Regulatory Post Marketing Commitment Plan) · completed
Other recruiting trials for Neuropathic Pain
Currently open trials in the same condition.
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- NCT07487610 — Relationship Between Neuropathic Pain and Geriatric Assessment Parameters in Patients Aged 80 Years and Older · recruiting
- NCT07436806 — SPS Block vs. Surgical Intercostal Block for Chronic Pain After Thoracoscopic Surgery · NA · recruiting
Other Pfizer's Upjohn has merged with Mylan to form Viatris Inc. trials
Trials by the same sponsor.
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- NCT03711708 — Relative Bioavailability Study of Zoloft Oral Solution to Zoloft Tablets · Phase 4 · completed
- NCT03342690 — Drug Use Investigation of Selara Tablets (an Investigation for Chronic Heart Failure) · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01279850 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Last refreshed: 26 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01279850.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing