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NCT04680156
Long-term Follow-up Durability (Efficacy) Study of EN3835 for the Treatment of AC of the Shoulder (Frozen Shoulder)
trial testing Previously treated with EN3835 up to 1.74 mg or Placebo in EN3835-210 or the pivotal phase 3 studies in Adhesive Capsulitis in 120 participants. Terminated before completion.
12 September 2022
Quick facts
| Lead sponsor | Endo Pharmaceuticals |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 120 |
| Start date | 17 December 2020 |
| Primary completion | 12 September 2022 |
| Estimated completion | 12 September 2022 |
| Sites | 30 locations across United States |
Drugs / interventions tested
- Previously treated with EN3835 up to 1.74 mg or Placebo in EN3835-210 or the pivotal phase 3 studies — full drug profile →
Conditions studied
- Adhesive Capsulitis — all drugs for Adhesive Capsulitis →
- Frozen Shoulder — all drugs for Frozen Shoulder →
Sponsor
Endo Pharmaceuticals — full company profile →
Who can join
18 and older, any sex, with Adhesive Capsulitis or Frozen Shoulder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a long-term follow-up study to evaluate the safety and durability (efficacy) of response to EN3835 compared to placebo in participants who were treated in EN3835-210 or the pivotal Phase 3 parent studies for the treatment of AC of the shoulder (frozen shoulder).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04680156
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Adhesive Capsulitis
Currently open trials in the same condition.
- NCT07486193 — Effects of Nunchaku Exercise for Improving Frozen Shoulder · NA · recruiting
- NCT07493213 — USG-Guided Shoulder Injections in Frozen Shoulder · NA · recruiting
- NCT07493226 — Efficacy of Chemically Distinct Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and Pain Phenotypes in Adhesive Capsulitis · NA · recruiting
- NCT07495306 — Electrophysiologic Changes After Extended 360° Capsular Release · recruiting
- NCT07410845 — Operative vs Non Operative Management of Adhesive Capsulitis: A Comparative Review · active not recruiting
Other Endo Pharmaceuticals trials
Trials by the same sponsor.
- NCT06169319 — A Study to Assess Collagenase Clostridium Histolyticum (CCH) in the Treatment of Plantar Fasciitis (PFA) · Phase 2 · completed
- NCT05873595 — Real-World Data Study to Understand Effectiveness of Treatments in Peyronie's Disease · terminated
- NCT05877066 — Real-World Data Study to Understand Participant Treatment Outcomes for Dupuytren's Contracture · terminated
- NCT05419505 — Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks · Phase 2 · completed
- NCT05254457 — Long-Term Safety, Efficacy, and Durability of EN3835 in the Treatment and Retreatment of Plantar Fibromatosis · Phase 3 · 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 NCT04680156 (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 Endo Pharmaceuticals
- Last refreshed: 30 December 2022
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/NCT04680156.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing