Adhesive CapsulitisNCT04680156
Long-term Follow-up Durability (Efficacy) Study of EN3835 for the Treatment of AC of the Shoulder (Frozen Shoulder)
An observational study of Adhesive Capsulitis and Frozen Shoulder, run by Endo USA Inc., a Keenova Therapeutics Company at 30 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adhesive Capsulitis, Frozen Shoulder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 30 sitesUnited States
- Study dates
- 17 Dec 2020to 12 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All participants that have completed the EN3835-210 study or the pivotal Phase 3 studies in which they were enrolled.
Who may be able to join
- 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).
- 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.
- Be willing to undergo MRI of the affected shoulder as required by the protocol.
- Be able to read, understand, and independently complete patient reported outcome instruments in English.
- Be willing and able to cooperate with the requirements of the study.
- Be adequately informed and understand the nature and risks of the study and be able to provide consent.
Who cannot join
- 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.
- 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).
- 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.
- Has any other conditions that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Endo Clinical Trial Site #30
Altoona, Pennsylvania, 16602
Endo Clinical Trial Site #6
Bedford, Texas, 76021
Endo Clinical Trial Site #17
Bellaire, Texas, 77401
Endo Clinical Trial Site #16
Birmingham, Alabama, 35243
Endo Clinical Trial Site #2
Clearwater, Florida, 33765
Endo Clinical Trial Site #26
Dalton, Georgia, 30720
Endo Clinical Trial Site #3
Danville, Virginia, 24541
Endo Clinical Trial Site #13
Dayton, Ohio, 45432
Endo Clinical Trial Site #29
Durham, North Carolina, 27704
Endo Clinical Trial Site #8
Encinitas, California, 92024
Endo Clinical Trial Site #19
Fort Lauderdale, Florida, 33318
Endo Clinical Trial Site #27
Georgetown, Texas, 78628
Endo Clinical Trial Site #7
Huntington Beach, California, 92647
Endo Clinical Trial Site #12
Indiana, Pennsylvania, 15701
Endo Clinical Trial Site #14
La Mesa, California, 91942
Endo Clinical Trial Site #22
Laredo, Texas, 78041
Endo Clinical Trial Site #20
Lawrenceville, Georgia, 30043
Endo Clinical Trial Site #9
Mobile, Alabama, 36609
Endo Clinical Trial Site #21
Newnan, Georgia, 30265
Endo Clinical Trial Site #23
Oak Brook, Illinois, 60523
Endo Clinical Trial Site #28
Oak Brook, Illinois, 60523
Endo Clinical Trial Site #11
Pasadena, California, 91105
Endo Clinical Trial Site #15
Plano, Texas, 75075
Endo Clinical Trial Site #18
Plano, Texas, 75093
Endo Clinical Trial Site #5
State College, Pennsylvania, 16801
Endo Clinical Trial Site #24
Stockbridge, Georgia, 30281
Endo Clinical Trial Site #10
Stony Brook, New York, 11794
Endo Clinical Trial Site #1
Tampa, Florida, 33606
Endo Clinical Trial Site #25
Tucson, Arizona, 85712
Endo Clinical Trial Site #4
Winter Park, Florida, 32789
About this study
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)
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).
- Conditions
- Adhesive Capsulitis, Frozen Shoulder
- Being tested
- Previously treated with EN3835 up to 1.74 mg or Placebo in EN3835-210 or the pivotal phase 3 studies
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Previously treated with EN3835 up to 1.74 mg or Placebo in EN3835-210 or the pivotal phase 3 studiesDrug
No treatment to be administered - Observational only
| Study group | Role | What they receive |
|---|---|---|
| EN3835 | Previously treated with EN3835 in EN3835-210 or the pivotal phase 3 studies Receives: Drug: Previously treated with EN3835 up to 1.74 mg or Placebo in EN3835-210 or the pivotal phase 3 studies | |
| Placebo | Previously treated Placebo in EN3835-210 or the pivotal phase 3 studies Receives: Drug: Previously treated with EN3835 up to 1.74 mg or Placebo in EN3835-210 or the pivotal phase 3 studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ASES composite score in affected shoulder
The change from Day 95/end of study (EOS) in the parent studies in the adapted American Shoulder and Elbow Society (ASES) composite score for the affected shoulder
Measured: Days 180, 270, and 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start17 Dec 2020
- Primary completion12 Sep 2022
- Study completion12 Sep 2022
Why it stopped: Lack of efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karen Kang, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680156
- Sponsor's protocol ID
- EN3835-223
- Status last verified
- Dec 2022
- First submitted
- 17 Dec 2020
- Last updated
- 30 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04680156
- Acronym / sponsor ID
- EN3835-223
- Conditions
- Adhesive Capsulitis, Frozen Shoulder
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of efficacy
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 12 Sep 2022 (actual)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EN3835 | – | Drug: Previously treated with EN3835 up to 1.74 mg or Placebo in EN3835-210 or the pivotal phase 3 studiesPreviously treated with EN3835 in EN3835-210 or the pivotal phase 3 studies |
| Placebo | – | Drug: Previously treated with EN3835 up to 1.74 mg or Placebo in EN3835-210 or the pivotal phase 3 studiesPreviously treated Placebo in EN3835-210 or the pivotal phase 3 studies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants that have completed the EN3835-210 study or the pivotal Phase 3 studies in which they were enrolled.
Key inclusion criteria (7 listed)
- 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).
- 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.
- Be willing to undergo MRI of the affected shoulder as required by the protocol.
- Be able to read, understand, and independently complete patient reported outcome instruments in English.
Key exclusion criteria (5 listed)
- 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.
- 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).
- 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.
- Has any other conditions that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Previously treated with EN3835 up to 1.74 mg or Placebo in EN3835-210 or the pivotal phase 3 studiesNo treatment to be administered - Observational only | Drug | EN3835, Placebo |
Primary outcome
Change in ASES composite score in affected shoulder
Time frame: Days 180, 270, and 360
The change from Day 95/end of study (EOS) in the parent studies in the adapted American Shoulder and Elbow Society (ASES) composite score for the affected shoulder
Results and safety
The study was stopped early (reason given: Lack of efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Kang study director
Endo USA Inc., a Keenova Therapeutics Company
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adhesive Capsulitis and Frozen Shoulder, run by Endo USA Inc., a Keenova Therapeutics Company at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of efficacy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ASES composite score in affected shoulder (time frame: Days 180, 270, and 360). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2022.