Ulcerative ColitisPhase 4NCT05684484
Role of Roflumilast in Ulcerative Colitis
A Phase 4 study testing Roflumilast 500 MCG Oral Tablet [DALIRESP] and amino salicylic acid in people with Ulcerative Colitis, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to investigate possible efficacy and safety of Roflumilast in adult patients with ulcerative colitis disease . Read more about this study
- Who is it for?
- Ages 15 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Roflumilast 500 MCG Oral Tablet [DALIRESP] and amino salicylic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 15 Sep 2024
- Phase
- Phase 4
- 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 15 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients referred to endoscopy units in Tanta University hospitals during the period of the study.
- Patient with mild to moderate UC diagnosed as:
- Clinical signs: Patients with moderate clinical disease have frequent loose, bloody stools (>4per day), mild anemia, and abdominal pain that is not severe. Patients have minimal signs of systemic toxicity, including a low-grade fever. Adequate nutrition is usually maintained, and weight loss.
- Endoscopy : are necessary to establish the chronicity of inflammation and to exclude other causes of colitis.
Who cannot join
- Other inflammatory bowel disease (crohn's disease) .
- Patients <15 and >80 years
- Patients who didn't give consent to participate in the study
- Patients with contraindications of colonoscopy e.g. suspected colonic perforation, acute peritonitis, pregnancy, severe bleeding tendency, shock, uncooperative patient and if toxic mega colon is suspected were excluded
- History of allergic reaction to Roflumilast or any component of the formulation Like rash , hives ,itching and redness .
- Depression , thoughts of suicide , anxiety and emotional instability .
Show all 10Show fewer
- Excessive weight loss .
- Moderate to severe hepatic impairment (child pugh class B or C) .
- Strong (CYP3A4) inducers : Barbiturates (phenobarbital) , Carbamazepine , Phenytoin , Rifampicin ( Risk , X interaction )
- Loxapine ( Risk , X interaction )
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Evaluate the Possible Efficacy and Safety of Roflumilast in Patients With Ulcerative Colitis.
This study aims to investigate possible efficacy and safety of Roflumilast in adult patients with ulcerative colitis disease .
Read the detailed description
- Study design and study population This study will be randomized, controlled, parallel study.
- It will be conducted on 52 patient having with mild to moderate degree ulcerative colitis disease divided into two groups
- Group 1 (n=26): Patients will receive conventional treatment only (corticosteroids +immune suppressive +amino salicylic acid) for 3 months.
- Group 2 (n=26): Patients will receive previous conventional treatment and Roflumilast (500 mcg ) orally once daily for 3 months
- Patient will be selected from Gastroenterology and Endoscopy Unit, Internal Medicine Department, Tanta University Hospital.
- A written informed consent will be obtained from all patients
- This study will be approved by the Research Ethics Committee of Tanta University.
- Any unexpected risks appeared during the course of research will be reported to the participants and ethical committee on time and documented through an adverse effects reporting form .
- Randomization will be carried out based on days of hospital admission
- Conditions
- Ulcerative Colitis
- Being tested
- Roflumilast 500 MCG Oral Tablet [DALIRESP], amino salicylic acid
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roflumilast 500 MCG Oral Tablet [DALIRESP]Drug
Also called phosphodiesterase type 4
Roflumilast has been approved by U.S. Food and Drug Administration (FDA) for attenuating bronchial and dermatological disorders
amino salicylic acidDrug
Also called mesalamine
conventional treatment
| Study group | Role | What they receive |
|---|---|---|
| mesalamine group | Placebo comparator | Placebo Group (n=26): Patients will receive mesalamine 500 mg once daily forulcerative colitis for 3 months. Receives: Drug: amino salicylic acid |
| Roflumilast group | Experimental | Patients will receive mesalamine and Roflumilast (500 mcg ) orally once daily for 3 months Receives: Drug: Roflumilast 500 MCG Oral Tablet [DALIRESP] |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical improvement in ulcerative colitis severity
To demonstrate the efficacy of Roflumilast and clinical improvement in (Mayo disease activity index) for assessment of ulcerative colitis severity
Measured: 3 months
Secondary outcomes (1)
changes in serum levels of the measured biochemical parameters
demonstrate changes in serum levels of the measured biochemical parameters
- Tumor necrosis factor-alpha (TNF-α) as pro inflammatory marker (ELISA).
- Signal transducer and activator of transcription 3 (STAT3) as a potential marker for apoptosis ( ELISA)
- Caspase-3 as a potential marker for apoptosis (ELISA).
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start1 Feb 2023
- Primary completion15 Apr 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It will be conducted on 52 patient having with mild to moderate degree ulcerative colitis disease divided into two groups 1. Placebo Group (n=26): Patients will receive conventional tratment only (amino salicylic acid) for 3 months. 2. Group 2 (n=26): Patients will receive conventional treatment and Roflumilast (500 mcg ) orally once daily for 3 months
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed magdy youness, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684484
- Sponsor's protocol ID
- Roflumilast ulcerative colitis
- Status last verified
- Jan 2025
- First submitted
- 26 Dec 2022
- Last updated
- 28 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Feuerstein JD, Cheifetz AS. Ulcerative colitis: epidemiology, diagnosis, and management. Mayo Clin Proc. 2014 Nov;89(11):1553-63. doi: 10.1016/j.mayocp.2014.07.002. Epub 2014 Sep 8.
PubMed 25199861Thrash B, Patel M, Shah KR, Boland CR, Menter A. Cutaneous manifestations of gastrointestinal disease: part II. J Am Acad Dermatol. 2013 Feb;68(2):211.e1-33; quiz 244-6. doi: 10.1016/j.jaad.2012.10.036.
PubMed 23317981Neurath MF. Targeting immune cell circuits and trafficking in inflammatory bowel disease. Nat Immunol. 2019 Aug;20(8):970-979. doi: 10.1038/s41590-019-0415-0. Epub 2019 Jun 24.
PubMed 31235952de Souza HSP, Fiocchi C, Iliopoulos D. The IBD interactome: an integrated view of aetiology, pathogenesis and therapy. Nat Rev Gastroenterol Hepatol. 2017 Dec;14(12):739-749. doi: 10.1038/nrgastro.2017.110. Epub 2017 Aug 23.
PubMed 28831186Elbadry M, Nour MO, Hussien M, Ghoneem EA, Medhat MA, Shehab H, Galal S, Eltabbakh M, El-Raey F, Negm M, Afify S, Abdelhamed W, Sherief A, Abdelaziz A, Abo Elkasem M, Mahrous A, Kamal G, Maher M, Abdel-Hameed O, Elbasuny A, El-Zayyadi I, Bassiony A, Moussa A, Bedewy E, Elfert A, El Kassas M. Clinico-Epidemiological Characteristics of Patients With Inflammatory Bowel Disease in Egypt: A Nationwide Multicenter Study. Front Med (Lausanne). 2022 Apr 19;9:867293. doi: 10.3389/fmed.2022.867293. eCollection 2022.
PubMed 35514748Fujita Y, Khateb A, Li Y, Tinoco R, Zhang T, Bar-Yoseph H, Tam MA, Chowers Y, Sabo E, Gerassy-Vainberg S, Starosvetsky E, James B, Brown K, Shen-Orr SS, Bradley LM, Tessier PA, Ronai ZA. Regulation of S100A8 Stability by RNF5 in Intestinal Epithelial Cells Determines Intestinal Inflammation and Severity of Colitis. Cell Rep. 2018 Sep 18;24(12):3296-3311.e6. doi: 10.1016/j.celrep.2018.08.057.
PubMed 30232010Zundler S, Becker E, Schulze LL, Neurath MF. Immune cell trafficking and retention in inflammatory bowel disease: mechanistic insights and therapeutic advances. Gut. 2019 Sep;68(9):1688-1700. doi: 10.1136/gutjnl-2018-317977. Epub 2019 May 24.
PubMed 31127023Trivedi PJ, Adams DH. Chemokines and Chemokine Receptors as Therapeutic Targets in Inflammatory Bowel Disease; Pitfalls and Promise. J Crohns Colitis. 2018 Nov 28;12(12):1508. doi: 10.1093/ecco-jcc/jjy130. No abstract available.
PubMed 30272117Zhang X, Dong G, Li H, Chen W, Li J, Feng C, Gu Z, Zhu F, Zhang R, Li M, Tang W, Liu H, Xu Y. Structure-Aided Identification and Optimization of Tetrahydro-isoquinolines as Novel PDE4 Inhibitors Leading to Discovery of an Effective Antipsoriasis Agent. J Med Chem. 2019 Jun 13;62(11):5579-5593. doi: 10.1021/acs.jmedchem.9b00518. Epub 2019 May 31.
PubMed 31099559Raker VK, Becker C, Steinbrink K. The cAMP Pathway as Therapeutic Target in Autoimmune and Inflammatory Diseases. Front Immunol. 2016 Mar 31;7:123. doi: 10.3389/fimmu.2016.00123. eCollection 2016.
PubMed 27065076Li H, Li J, Zhang X, Feng C, Fan C, Yang X, Zhang R, Zhu F, Zhou Y, Xu Y, Liu H, Tang W. DC591017, a phosphodiesterase-4 (PDE4) inhibitor with robust anti-inflammation through regulating PKA-CREB signaling. Biochem Pharmacol. 2020 Jul;177:113958. doi: 10.1016/j.bcp.2020.113958. Epub 2020 Apr 3.
PubMed 32251674Li H, Fan C, Feng C, Wu Y, Lu H, He P, Yang X, Zhu F, Qi Q, Gao Y, Zuo J, Tang W. Inhibition of phosphodiesterase-4 attenuates murine ulcerative colitis through interference with mucosal immunity. Br J Pharmacol. 2019 Jul;176(13):2209-2226. doi: 10.1111/bph.14667. Epub 2019 May 17.
PubMed 30883697Zebda R, Paller AS. Phosphodiesterase 4 inhibitors. J Am Acad Dermatol. 2018 Mar;78(3 Suppl 1):S43-S52. doi: 10.1016/j.jaad.2017.11.056. Epub 2017 Dec 15.
PubMed 29248522Kokkonen K, Kass DA. Nanodomain Regulation of Cardiac Cyclic Nucleotide Signaling by Phosphodiesterases. Annu Rev Pharmacol Toxicol. 2017 Jan 6;57:455-479. doi: 10.1146/annurev-pharmtox-010716-104756. Epub 2016 Oct 12.
PubMed 27732797Faleiro L, Kobayashi R, Fearnhead H, Lazebnik Y. Multiple species of CPP32 and Mch2 are the major active caspases present in apoptotic cells. EMBO J. 1997 May 1;16(9):2271-81. doi: 10.1093/emboj/16.9.2271.
PubMed 9171342
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Possible Efficacy and Safety of Roflumilast in Patients With Ulcerative Colitis.
- ClinicalTrials.gov ID
- NCT05684484
- Acronym / sponsor ID
- Roflumilast ulcerative colitis
- Conditions
- Ulcerative Colitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 13 Jan 2023 (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 study aims to investigate possible efficacy and safety of Roflumilast in adult patients with ulcerative colitis disease .
Detailed description
- Study design and study population This study will be randomized, controlled, parallel study.
- It will be conducted on 52 patient having with mild to moderate degree ulcerative colitis disease divided into two groups
- Group 1 (n=26): Patients will receive conventional treatment only (corticosteroids +immune suppressive +amino salicylic acid) for 3 months.
- Group 2 (n=26): Patients will receive previous conventional treatment and Roflumilast (500 mcg ) orally once daily for 3 months
- Patient will be selected from Gastroenterology and Endoscopy Unit, Internal Medicine Department, Tanta University Hospital.
- A written informed consent will be obtained from all patients
- This study will be approved by the Research Ethics Committee of Tanta University.
- Any unexpected risks appeared during the course of research will be reported to the participants and ethical committee on time and documented through an adverse effects reporting form .
- Randomization will be carried out based on days of hospital admission
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It will be conducted on 52 patient having with mild to moderate degree ulcerative colitis disease divided into two groups 1. Placebo Group (n=26): Patients will receive conventional tratment only (amino salicylic acid) for 3 months. 2. Group 2 (n=26): Patients will receive conventional treatment and Roflumilast (500 mcg ) orally once daily for 3 months
| Arm | Type | Receives |
|---|---|---|
| mesalamine group | Placebo comparator | Drug: amino salicylic acidPlacebo Group (n=26): Patients will receive mesalamine 500 mg once daily forulcerative colitis for 3 months. |
| Roflumilast group | Experimental | Drug: Roflumilast 500 MCG Oral Tablet [DALIRESP]Patients will receive mesalamine and Roflumilast (500 mcg ) orally once daily for 3 months |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients referred to endoscopy units in Tanta University hospitals during the period of the study.
- Clinical signs: Patients with moderate clinical disease have frequent loose, bloody stools (>4per day), mild anemia, and abdominal pain that is not severe. Patients have minimal signs of systemic toxicity, including a low-grade fever. Adequate nutrition is usually maintained, and weight loss.
- Endoscopy : are necessary to establish the chronicity of inflammation and to exclude other causes of colitis.
Key exclusion criteria (10 listed)
- Other inflammatory bowel disease (crohn's disease) .
- Patients <15 and >80 years
- Patients who didn't give consent to participate in the study
- Patients with contraindications of colonoscopy e.g. suspected colonic perforation, acute peritonitis, pregnancy, severe bleeding tendency, shock, uncooperative patient and if toxic mega colon is suspected were excluded
- History of allergic reaction to Roflumilast or any component of the formulation Like rash , hives ,itching and redness .
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 |
|---|---|---|
| Roflumilast 500 MCG Oral Tablet [DALIRESP]Also: phosphodiesterase type 4Roflumilast has been approved by U.S. Food and Drug Administration (FDA) for attenuating bronchial and dermatological disorders | Drug | Roflumilast group |
| amino salicylic acidAlso: mesalamineconventional treatment | Drug | mesalamine group |
Primary outcome
clinical improvement in ulcerative colitis severity
Time frame: 3 months
To demonstrate the efficacy of Roflumilast and clinical improvement in (Mayo disease activity index) for assessment of ulcerative colitis severity
1 secondary outcome
changes in serum levels of the measured biochemical parameters
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Background: PubMed 25199861Feuerstein JD, Cheifetz AS. Ulcerative colitis: epidemiology, diagnosis, and management. Mayo Clin Proc. 2014 Nov;89(11):1553-63. doi: 10.1016/j.mayocp.2014.07.002. Epub 2014 Sep 8.
- Background: PubMed 23317981Thrash B, Patel M, Shah KR, Boland CR, Menter A. Cutaneous manifestations of gastrointestinal disease: part II. J Am Acad Dermatol. 2013 Feb;68(2):211.e1-33; quiz 244-6. doi: 10.1016/j.jaad.2012.10.036.
- Background: PubMed 31235952Neurath MF. Targeting immune cell circuits and trafficking in inflammatory bowel disease. Nat Immunol. 2019 Aug;20(8):970-979. doi: 10.1038/s41590-019-0415-0. Epub 2019 Jun 24.
- Background: PubMed 28831186de Souza HSP, Fiocchi C, Iliopoulos D. The IBD interactome: an integrated view of aetiology, pathogenesis and therapy. Nat Rev Gastroenterol Hepatol. 2017 Dec;14(12):739-749. doi: 10.1038/nrgastro.2017.110. Epub 2017 Aug 23.
- Background: PubMed 35514748Elbadry M, Nour MO, Hussien M, Ghoneem EA, Medhat MA, Shehab H, Galal S, Eltabbakh M, El-Raey F, Negm M, Afify S, Abdelhamed W, Sherief A, Abdelaziz A, Abo Elkasem M, Mahrous A, Kamal G, Maher M, Abdel-Hameed O, Elbasuny A, El-Zayyadi I, Bassiony A, Moussa A, Bedewy E, Elfert A, El Kassas M. Clinico-Epidemiological Characteristics of Patients With Inflammatory Bowel Disease in Egypt: A Nationwide Multicenter Study. Front Med (Lausanne). 2022 Apr 19;9:867293. doi: 10.3389/fmed.2022.867293. eCollection 2022.
- Background: PubMed 30232010Fujita Y, Khateb A, Li Y, Tinoco R, Zhang T, Bar-Yoseph H, Tam MA, Chowers Y, Sabo E, Gerassy-Vainberg S, Starosvetsky E, James B, Brown K, Shen-Orr SS, Bradley LM, Tessier PA, Ronai ZA. Regulation of S100A8 Stability by RNF5 in Intestinal Epithelial Cells Determines Intestinal Inflammation and Severity of Colitis. Cell Rep. 2018 Sep 18;24(12):3296-3311.e6. doi: 10.1016/j.celrep.2018.08.057.
- Background: PubMed 31127023Zundler S, Becker E, Schulze LL, Neurath MF. Immune cell trafficking and retention in inflammatory bowel disease: mechanistic insights and therapeutic advances. Gut. 2019 Sep;68(9):1688-1700. doi: 10.1136/gutjnl-2018-317977. Epub 2019 May 24.
- Background: PubMed 30272117Trivedi PJ, Adams DH. Chemokines and Chemokine Receptors as Therapeutic Targets in Inflammatory Bowel Disease; Pitfalls and Promise. J Crohns Colitis. 2018 Nov 28;12(12):1508. doi: 10.1093/ecco-jcc/jjy130. No abstract available.
- Background: PubMed 31099559Zhang X, Dong G, Li H, Chen W, Li J, Feng C, Gu Z, Zhu F, Zhang R, Li M, Tang W, Liu H, Xu Y. Structure-Aided Identification and Optimization of Tetrahydro-isoquinolines as Novel PDE4 Inhibitors Leading to Discovery of an Effective Antipsoriasis Agent. J Med Chem. 2019 Jun 13;62(11):5579-5593. doi: 10.1021/acs.jmedchem.9b00518. Epub 2019 May 31.
- Background: PubMed 27065076Raker VK, Becker C, Steinbrink K. The cAMP Pathway as Therapeutic Target in Autoimmune and Inflammatory Diseases. Front Immunol. 2016 Mar 31;7:123. doi: 10.3389/fimmu.2016.00123. eCollection 2016.
- Background: PubMed 32251674Li H, Li J, Zhang X, Feng C, Fan C, Yang X, Zhang R, Zhu F, Zhou Y, Xu Y, Liu H, Tang W. DC591017, a phosphodiesterase-4 (PDE4) inhibitor with robust anti-inflammation through regulating PKA-CREB signaling. Biochem Pharmacol. 2020 Jul;177:113958. doi: 10.1016/j.bcp.2020.113958. Epub 2020 Apr 3.
- Background: PubMed 30883697Li H, Fan C, Feng C, Wu Y, Lu H, He P, Yang X, Zhu F, Qi Q, Gao Y, Zuo J, Tang W. Inhibition of phosphodiesterase-4 attenuates murine ulcerative colitis through interference with mucosal immunity. Br J Pharmacol. 2019 Jul;176(13):2209-2226. doi: 10.1111/bph.14667. Epub 2019 May 17.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Roflumilast 500 MCG Oral Tablet [DALIRESP] and amino salicylic acid in people with Ulcerative Colitis, run by Tanta University at 1 site in Egypt.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
clinical improvement in ulcerative colitis severity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05684484, which also lists 16 linked publications.
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 28 Jan 2025.