Last reviewed · How we verify
NCT00240032
A Double-Blind, Randomized, Placebo Controlled Study of An Oral Antihistamine on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone® Using Autoject® 2 for Glass Syringe.
Phase 4 trial testing glatiramer acetate injection with oral cetirizine hydrochloride in Multiple Sclerosis in 80 participants. Completed in 1 July 2006.
1 June 2006
Quick facts
| Lead sponsor | Teva Branded Pharmaceutical Products R&D, Inc. |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 1 October 2004 |
| Primary completion | 1 June 2006 |
| Estimated completion | 1 July 2006 |
Drugs / interventions tested
- glatiramer acetate injection with oral cetirizine hydrochloride — full drug profile →
- glatiramer acetate with placebo — full drug profile →
Conditions studied
- Multiple Sclerosis — all drugs for Multiple Sclerosis →
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc. — full company profile →
Who can join
18 and older, any sex, with Multiple Sclerosis. 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.
-
Injection Site Reaction
Time frame: 5 weeks
Injection site reaction after taking antihistamine
Sponsor's own description
This study is designed to compare injection skin (injection site) reactions when an antihistamine (Zyrtec®) or placebo is taken prior to performing daily Copaxone® injections. Patients will be assigned (like a flip of a coin) to take either a placebo or an antihistamine (Zyrtec®) prior to performing their daily Copaxone® injections. The patient and physician will be unaware whether they are taking a placebo or antihistamine during the study.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Repurposing of H<sub>1</sub>-receptor antagonists (levo)cetirizine, (des)loratadine, and fexofenadine as a case study for systematic analysis of trials on clinicaltrials.gov using semi-automated processes with custom-coded software.
Specht T, Seifert R. · · 2024 · cited 5× · PMID 37870580 · DOI 10.1007/s00210-023-02796-9
Verify or expand the search:
- PubMed search for NCT00240032
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Multiple Sclerosis
Currently open trials in the same condition.
- NCT07507084 — The Effect of Internal- or External-Focused Exercise Training, Administered in Conjunction With a Cognitive Task, on Wal · NA · recruiting
- NCT07524231 — Evaluation of the Effects of Laughter Yoga · NA · recruiting
- NCT07489794 — URINARY INCONTINENCE AND PELVIC FLOOR MUSCLE ACTIVITY IN MULTIPLE SCLEROSIS · recruiting
- NCT07236684 — Identification of Factors Related to UI in Patients With MS and EMG Assessment of PFM Activity · recruiting
- NCT07500727 — Skeletal Muscle Aging and Responsiveness in Aged People With MS · NA · recruiting
Other Teva Branded Pharmaceutical Products R&D, Inc. trials
Trials by the same sponsor.
- NCT06664619 — A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate · Phase 3 · recruiting
- NCT06627231 — Mass Balance Clinical Trial With TEV-56286 · Phase 1 · completed
- NCT06480552 — An Open-label Dose Escalation/Expansion Trial to Evaluate the Safety and Anti-tumor Activity of TEV-56278 Alone or in Co · Phase 1 · recruiting
- NCT06290102 — Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluti · Phase 1 · completed
- NCT06253546 — Safety, Tolerability, and Pharmacokinetic Study of TV-44749 in Chinese Patients With Schizophrenia · Phase 1 · 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 NCT00240032 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Teva Branded Pharmaceutical Products R&D, Inc.
- Last refreshed: 7 April 2011
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/NCT00240032.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing