Clinical trial NCT04680156: Long-term Follow-up Durability (Efficacy) Study of EN3835 for the Treatment of AC of the Shoulder (Frozen Shoulder)
Official title: An Observational, Double-blind (Sponsor Open), Long-term Study to Evaluate the Safety and Durability (Efficacy) of Response to EN3835 Compared to Placebo in the Treatment of Adhesive Capsulitis of the Shoulder (Frozen Shoulder)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Adhesive Capsulitis
Frozen Shoulder
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-12-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants that have completed the EN3835-210 study or the pivotal Phase 3 studies in which they were enrolled.

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

1. Have been enrolled and completed the EN3835-210 or pivotal Phase 3 parent studies (for Study EN3835-223 eligibility, completed participants are those who were assessed for safety and obtained ASES scores at Day 95/EOS Visit; does not include early terminated participants).
2. Be willing not to use pain medications for the duration of the study period and for 2 weeks prior to the Day 180 visit. Pain medications include but are not limited to: barbiturates, benzodiazepines, methadone, buprenorphine, opioids (e.g., codeine, heroin, hydrocodone, hydromorphone, morphine, oxycodone), and cannabis.

   Note: NSAIDs (ibuprofen, etc.) are allowed.
3. Be willing to undergo MRI of the affected shoulder as required by the protocol.
4. Be able to read, understand, and independently complete patient reported outcome instruments in English.
5. Be willing and able to cooperate with the requirements of the study.
6. Be adequately informed and understand the nature and risks of the study and be able to provide consent.

Exclusion Criteria:

1. Is from a vulnerable population, as defined by the US Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full time, etc.) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the IRB/IEC.
2. Plans to receive (or received prior to Day 180) any invasive or minimally invasive (ie, steroid injections, shoulder manipulation, surgery, etc.) procedures to the affected shoulder during study participation.

   Note: PT is allowed. Any PT received should be captured in the respective electronic case report form (eCRF).
3. Has any contraindications for MRI (implant containing metal, internal metallic object, permanent cosmetics/make-up/tattoos-with exemption of the area to be treated/reviewed, claustrophobia, syncope, low blood pressure, epilepsy, asthma, anemia, or sickle cell disease) as determined by the technologist, the radiologist, and/or investigator performing imaging.
4. Has any other conditions that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.

Primary outcomes:
measure: Change in ASES composite score in affected shoulder
timeFrame: Days 180, 270, and 360
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Endo Clinical Trial Site #16
state: Alabama
city: Mobile
country: United States
facility: Endo Clinical Trial Site #9
state: Alabama
city: Tucson
country: United States
facility: Endo Clinical Trial Site #25
state: Arizona
city: Encinitas
country: United States
facility: Endo Clinical Trial Site #8
state: California
city: Huntington Beach
country: United States
facility: Endo Clinical Trial Site #7
state: California
city: La Mesa
country: United States
facility: Endo Clinical Trial Site #14
state: California
city: Pasadena
country: United States
facility: Endo Clinical Trial Site #11
state: California
city: Clearwater
country: United States
facility: Endo Clinical Trial Site #2
state: Florida
city: Fort Lauderdale
country: United States
facility: Endo Clinical Trial Site #19
state: Florida
city: Tampa
country: United States
facility: Endo Clinical Trial Site #1
state: Florida
city: Winter Park
country: United States
facility: Endo Clinical Trial Site #4
state: Florida
city: Dalton
country: United States
facility: Endo Clinical Trial Site #26
state: Georgia
city: Lawrenceville
country: United States
facility: Endo Clinical Trial Site #20
state: Georgia
city: Newnan
country: United States
facility: Endo Clinical Trial Site #21
state: Georgia
city: Stockbridge
country: United States
facility: Endo Clinical Trial Site #24
state: Georgia
city: Oak Brook
country: United States
facility: Endo Clinical Trial Site #23
state: Illinois
city: Oak Brook
country: United States
facility: Endo Clinical Trial Site #28
state: Illinois
city: Stony Brook
country: United States
facility: Endo Clinical Trial Site #10
state: New York
city: Durham
country: United States
facility: Endo Clinical Trial Site #29
state: North Carolina
city: Dayton
country: United States
facility: Endo Clinical Trial Site #13
state: Ohio
city: Altoona
country: United States
facility: Endo Clinical Trial Site #30
state: Pennsylvania
city: Indiana
country: United States
facility: Endo Clinical Trial Site #12
state: Pennsylvania
city: State College
country: United States
facility: Endo Clinical Trial Site #5
state: Pennsylvania
city: Bedford
country: United States
facility: Endo Clinical Trial Site #6
state: Texas
city: Bellaire
country: United States
facility: Endo Clinical Trial Site #17
state: Texas
city: Georgetown
country: United States
facility: Endo Clinical Trial Site #27
state: Texas
city: Laredo
country: United States
facility: Endo Clinical Trial Site #22
state: Texas
city: Plano
country: United States
facility: Endo Clinical Trial Site #15
state: Texas
city: Plano
country: United States
facility: Endo Clinical Trial Site #18
state: Texas
city: Danville
country: United States
facility: Endo Clinical Trial Site #3
state: Virginia
Study officials:
affiliation: Endo Pharmaceuticals
name: Karen Kang
role: STUDY_DIRECTOR
References: