14 completed, 3 unknown, 2 active not recruiting, 1 withdrawn. 7 Phase 4, 5 Not applicable, 3 Phase 1, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 7 | Completed 4, Unknown 2, Withdrawn 1 |
| Not applicable | 5 | Completed 4, Unknown 1 |
| Phase 1 | 3 | Completed 2, Active not recruiting 1 |
| Phase 2 | 2 | Completed 2 |
Follow this condition Literature Review of Injection Site Reaction trials Research Report on Injection Site Reaction
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV Cabotegravir long-acting, Lenacapavir long-acting - HIV Infections | Phase 1 | Active not recruiting | ViiV Healthcare | 65 | 2025-04-22 | 2025-11-28 |
| Long-Term Real-World Evidence Study to Evaluate Effectiveness, Persistence, Adherence, Safety and Tolerability of Long-acting Cabotegravir Plus Rilpivirine. Human Immunodeficiency Virus Infection (HIV), HIV-1 Infection in Adults | Active not recruiting | FUNDACIÓN HOSPITAL UNIVERSITARIO INFANTA LEONOR Y DEL HOSPITAL UNIVERSITARIO DEL SURESTE | 3346 | 2024-12-31 | 2026-07-14 | |
| Prospective Study to Assess Tissue Responses After Injection With Biostimulatory Products Injection - Injection Site Reaction | Not applicable | Completed | Merz North America, Inc. | 20 | 2023-09-08 | 2026-09-22 |
| Safety of Pediatric COVID-19 Vaccination Observational - Pain, Injection Site Reaction | Completed | Duke University | 299 | 2022-04-06 | 2026-07-01 | |
| Simultaneous mRNA COVID-19 and IIV4 Vaccination Study mRNA COVID-19, IIV4, Placebo (saline) - Quality of Life, Injection Site Reaction | Phase 4 | Completed | Duke University | 348 | 2021-10-04 | 2024-03-19 |
| Simultaneous RZV and aIIV4 Vaccination FLUAD® Quadrivalent, Fluzone® High-Dose Quadrivalent, SHINGRIX® - Pain, Quality of Life | Phase 4 | Completed | Duke University | 267 | 2021-09-21 | 2024-07-11 |
| Evaluation of Deltoid Exercises on Injection Site Pain After (BNT162b2) COVID - 19 Vaccination exercise - Vaccines, Adverse Effects, Injection Site Reaction | Not applicable | Completed | Bursa Yuksek Ihtisas Training and Research Hospital | 401 | 2021-09-01 | 2022-01-11 |
| Sorrel 25R Injector - Sorrel Clinical Study Protocol Sorrel Wearable Injector - Injection Site, Injection Site Reaction | Not applicable | Unknown | Eitan Medical | 20 | 2021-08-23 | 2022-02-03 |
| Naldebain and Video-assisted Thoracoscopic Surgery Nalbuphine Sebacate or Sesame oil (placebo) - Analgesia, Nausea and Vomiting, Postoperative | Phase 4 | Unknown | Kaohsiung Medical University Chung-Ho Memorial Hospital | 60 | 2021-07-07 | 2024-03-21 |
| Can Epinephrine Coated Syringe for Subcutaneous Immunotherapy (SCIT) Reduce Large Local Reaction? Epinephrine or normal saline - Injection Reactions Site, Systemic Reactions | Phase 1 / Phase 2 | Completed | Mahidol University | 17 | 2018-10-24 | 2020-02-20 |
| A Post-Authorization Safety Study of Interferon Beta Therapy in Participants With Multiple Sclerosis SC Peginterferon beta-1a, SC interferon beta-1a, SC interferon beta-1b - Multiple Sclerosis, Relapsing-Remitting | Completed | Biogen | 626 | 2017-11-27 | 2019-09-25 | |
| Evaluating the Use of Prednisone to Decrease Pegylated Interferon Beta-1a Side Effects Plegridy, Prednisone, Tylenol Pill - Multiple Sclerosis | Phase 4 | Unknown | Holy Name Medical Center, Inc. | 50 | 2017-09-25 | 2019-08-15 |
| FLUAD® vs. Fluzone® High-Dose Study FLUAD®, Fluzone® High-Dose - Pain, Quality of Life | Phase 4 | Completed | Duke University | 757 | 2017-08-28 | 2021-03-30 |
| A Study Comparing the Local Tolerability of Two Subcutaneous Heparins in Healthy Volunteers. Sodium chloride - Injection Site Reaction | Phase 4 | Completed | Aspen Global Incorporated | 15 | 2016-06-02 | 2019-02-15 |
| Brimonidine Tartrate for the Treatment of Injection Related Erythema peginterferon beta-1a, brimonidine tartrate, Vehicle Gel - Relapsing-Remitting Multiple Sclerosis (RRMS) | Phase 4 | Withdrawn | Biogen | 2016-02-01 | 2016-04-25 | |
| Transgender, Silicone and Blood Smear Injection; Complications, Sepsis, Injection Site Disorder | Completed | Assistance Publique - Hôpitaux de Paris | 66 | 2015-07-01 | 2016-01-25 | |
| Effectiveness of Mechano-Analgesia and Cold Application on Ecchymosis, Pain and Satisfaction at Subcutaneous Heparin Injection ShotBlocker, Ice pack - Injection Site Reaction, Injection Site Bruising | Not applicable | Completed | Istanbul Saglik Bilimleri University | 165 | 2015-03-02 | 2018-08-24 |
| Study to Evaluate the Need of Needle Change for Application of Intramuscular, Subcutaneous and Intradermal Injection. needle exchange - Knowledge, Attitudes, Practice, Injection Site Reactions | Not applicable | Completed | Hospital M'Boi Mirim | 1240 | 2009-06-01 | 2011-01-07 |
| Examination of Dermatologic Effects From Subcutaneous Injections of ISIS 113715 ISIS 113715 - Type 2 Diabetes Mellitus | Phase 1 | Completed | Ionis Pharmaceuticals, Inc. | 10 | 2006-08-01 | 2007-10-17 |
| Study to Assess Safety and Quality of Life of Patients Using Biojector Versus Needles for Fuzeon Administration Biojector - Human Immunodeficiency Virus | Phase 2 | Completed | Canadian Immunodeficiency Research Collaborative | 337 | 2005-05-01 | 2012-06-05 |
Drug-Related Side Effects and Adverse Reactions (4) · Influenza, Human (3) · Pain (3) · Acquired Immunodeficiency Syndrome (2) · Agnosia (2) · Multiple Sclerosis, Relapsing-Remitting (2) · Behavior (1) · COVID-19 (1) · Demyelinating Diseases (1) · Diabetes Mellitus, Type 2 (1) · Ecchymosis (1) · Erythema (1) · HIV Infections (1) · Motor Activity (1)
Chemically-Induced Disorders (20) · Extravasation of Diagnostic and Therapeutic Materials (20) · Pathologic Processes (20) · Pathological Conditions, Signs and Symptoms (20) · Drug-Related Side Effects and Adverse Reactions (16) · Infections (7) · Signs and Symptoms (7) · Immune System Diseases (6) · RNA Virus Infections (6) · Virus Diseases (6) · Nervous System Diseases (5) · Neurologic Manifestations (5) · Autoimmune Diseases (3) · Autoimmune Diseases of the Nervous System (3) · Blood-Borne Infections (3)
peginterferon beta-1a (3) · Influenza Vaccines (2) · Sodium Chloride (2) · 2019-nCoV Vaccine mRNA-1273 (1) · Acetaminophen (1) · Brimonidine Tartrate (1) · Epinephrine (1) · Exercise (1) · ISIS-113715 (1) · Injections (1) · Interferon beta-1a (1) · Interferon beta-1b (1) · Prednisone (1) · Saline Solution (1) · Sesame Oil (1)
Duke University (4) · Biogen (2) · Aspen Global Incorporated (1) · Assistance Publique - Hôpitaux de Paris (1) · Bursa Yuksek Ihtisas Training and Research Hospital (1) · Canadian Immunodeficiency Research Collaborative (1) · Eitan Medical (1) · FUNDACIÓN HOSPITAL UNIVERSITARIO INFANTA LEONOR Y DEL HOSPITAL UNIVERSITARIO DEL SURESTE (1) · Holy Name Medical Center, Inc. (1) · Hospital M'Boi Mirim (1) · Ionis Pharmaceuticals, Inc. (1) · Istanbul Saglik Bilimleri University (1) · Kaohsiung Medical University Chung-Ho Memorial Hospital (1) · Mahidol University (1) · Merz North America, Inc. (1)
United States (8) · Spain (2) · Brazil (1) · Canada (1) · France (1) · Germany (1) · Taiwan (1) · Thailand (1) · Turkey (Türkiye) (1)
Kenneth Schmader, MD (2) · Ann P Marx, MD (1) · Elizabeth Barnett, MD (1) · Elizabeth Schlaudecker, MD, MPH (1) · Emmanuel B Walter, MD, MPH (1) · Fabrice Bouscarat, MD (1) · Hung-Te Hsu, MD, PhD (1) · Karen R Broder, MD (1) · Kawsar Talaat, MD (1) · Luiz Carlos R Lamblet, Nurse (1) · Marc C Torjman (1) · Mark K Wedel, MD, JD, FACP (1) · Michael J Smith, MD (1) · Mona Loutfy, MD, FRCP(C) (1)
PMID 15304586, PMID 17588298, PMID 17650835, PMID 21195945, PMID 22030569, PMID 26263287, PMID 33443580, PMID 37393237, PMID 37781954, PMID 39446325, PMID 39504023, PMID 40382572, PMID 41380398, PMID 9633761
2015 (1)